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MComes RPH

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  1. Can Parkinson's be stopped

    You are so very welcome.
  2. Can Parkinson's be stopped

    I thought most of you would be interested in this, so I decided to post this article from The BBC Health and Science section First hints Parkinson's can be stopped By James GallagherHealth and science reporter, BBC News website 4 August 2017 Share this with Facebook Share this with Twitter Share Image copyrightGETTY IMAGES It may be possible to stop the progression of Parkinson's disease with a drug normally used in type 2 diabetes, a clinical trial suggests. Current drugs help manage the symptoms, but do not prevent brain cells dying. The trial on 62 patients, published in the Lancet, hints the medicine halted the progression of the disease. The University College London (UCL) team is "excited", but it urges caution as any long-term benefit is uncertain and the drug needs more testing. "There's absolutely no doubt the most important unmet need in Parkinson's is a drug to slow down disease progression, it's unarguable," Prof Tom Foltynie, one of the researchers, told the BBC. In Parkinson's, the brain is progressively damaged and the cells that produce the hormone dopamine are lost. It leads to a tremor, difficulty moving and eventually memory problems. Therapies help manage symptoms by boosting dopamine levels, but the death of the brain continues and the disease gets worse. No drug stops that happening. 'First' In the trial, half of patients were given the diabetes drug exenatide and the rest were given a placebo (dummy treatment). All the patients stayed on their usual medication. As expected, those on just their usual medication declined over 48 weeks of treatment. But those given exenatide were stable. And three months after the experimental treatment stopped, those who had been taking exenatide were still better off. Prof Foltynie told the BBC News website: "This is the first clinical trial in actual patients with Parkinson's where there has been anything like this size of effect. "It gives us confidence exenatide is not just masking symptoms, it's doing something to the underlying disease. "We have to be excited and encouraged, but also cautious as we need to replicate these findings." Parkinson's disease 'may start in gut' Century-old Parkinson's question answered Experts excited by brain 'wonder-drug' Early days They also need to trial the drug for much longer periods of time. An effective drug would need to hold back the disease for years in order to make a significant difference to patients. Parkinson's progresses slowly and the difference in this 60-week trial was definitely there, but was "trivial" in terms of the impact on day-to-day life, say the researchers. The drug helps control blood sugar levels in diabetes by acting on a hormone sensor called GLP-1. Those sensors are found in brain cells too. It is thought the drug makes those cells work more efficiently or helps them to survive. It is why the drug is being tested in other neurodegenerative diseases including Alzheimer's. David Dexter, the deputy director of research at Parkinson's UK, said: "The findings offer hope that drugs like exenatide can slow the course of Parkinson's -  something no current treatment can do. "Because Parkinson's can progress quite gradually, this study was probably too small and short to tell us whether exenatide can halt the progression of the condition, but it's certainly encouraging and warrants further investigation." Dr Brian Fiske, from the The Michael J Fox Foundation for Parkinson's Research, said: "The results from the exenatide studies justify continued testing, but clinicians and patients are urged not to add exenatide to their regimens until more is known about their safety and impact on Parkinson's." Follow James on Twitter
  3. trazadone

    Noah, Thanks, I'm here to help. Sometimes it may take a few days, but I try to stay on top of things. What I would do in your case is take the 25mg of Trazadone and continue the Melatonin. You only want to change one thing at a time, so that way you can narrow down the issue. If all goes well, after 3 days you can then discontinue the Melatonin. I hope this helps and please keep me updated.
  4. trazadone

    Noah, There should be no withdrawal with either, but make sure you only take away one at a time. I would start with the Melatonin first. I hope this helps and please keep me posted.
  5. Gabapentin for Sleep

    Calprof54, I have not heard of the practice of using Gabapentin for sleep unless the lack of sleep is associated with some sort of nerve pain issue. Some of the side effects may be drowsiness, unsteadyness, dizziness, dry mouth, fatigue, and confusion. More commonly I have seen certain antidepressants, Seroquel or Trazadone, used to help with sleep. there are very few side effects, other than drowsiness, at the low dose when it used for sleep issues. I personally used the Trazadone and have had great success with it and have had very little, if any, drug hangover in the morning. I hope this helps and please keep me posted.
  6. Rytary vs. Sinemet ER

    Sherry, I have heard this happening to other people who switched from Regular Sinemet to Rytary, including myself. I changed the dose of Rytary over a matter of 3 months with no relief in symptoms. It was at that point that my Dr. and I tried Sinemet ER and we have not looked back. Rytary has worked great for so many people, but there are some that did not get a smooth transition without relief of symptoms or symptoms getting worse. My advice would be to try to transition to the Sinemet CR now, so you can see if it works for you. The Sinemet CR comes in 2 strengths, CR 25/100 and CR 50/200. As I always say, it is best to "start low and go slow" when starting a new medication. The Dr. may start you off with the CR 25/100, which can be taken anywhere from one to three times a day. You may probably notice a difference in symptoms anywhere from 3 to 5 days or up to 1 month at the longest. As far as an antidepressant, Effexor is in the class of antidepressants known as SSNRI's (Selective Serotonin Norepinephrine Reuptake Inhibitor), which works on 2 different neuroreceptors. A change in class may help with feelings of emotion. A possible change to a SSRI (Selective Serotonin Reuptake Inhibitor) only works on one neuroreceptor. Out of this class I have seen Lexapro used quite effectively in Parkinson related depression. Other choices may be Zoloft, Paxil, and Celexa. I hope this helps and please keep me posted.
  7. Can Parkinson's be stopped

    Otolorin, I agree with you that there is a chance that other medications may help with PD, but to just start trying other medications would be a task upon itself. Usually when a drung company finds out that their medication may work on other issues is usually by accident. Here are a few examples: 1- Minoxidil is marketed as a blood pressure medication, but the researchers found that it caused the side effect of hair growth. Now we can find it in a topical form, Rogaine, over the counter. 2- Benadryl is marketed as an antihistamine for allergies. During the research phase it was found to cause drowsiness. At one point not to long ago, it was the number one sleep aid used in hospitals. 3- There are also many examples of older antidepressants, like Trazadone, are better used now as sleep aides than what they are as antidepressants. I guess to make a long story short, one a medication is found to possibly help with a different ailment, that drug company and others will look at the whole class of those medications to see if they can be the first to market with an older medication with a new indication. This can then turn into more money because that older generic medication can then get a new Brand name and be sold for a higher price. I hope this helps and please keep me posted.
  8. Otolorin, It is always good to here from you and I do have an answer for this. I know it sounds a bit ridiculous that a medication that has already been approved for human consumption for one ailment cannot be tried in humans for a study in another ailment. The reason is that the FDA requires that any drug company that is trying to prove that their medication can be used for another condition will have to go through the same clinical trials as if it were a new medication. I see both sides of it because I am a pharmacist and a person with Parkinson's Disease. The scientist in me completely agrees with this rule because it is better to find a side effect, no matter how small or big, on an animal than a human. Being a person with Parkinson's, if some told me to eating the bark of an Oak tree would help me, I would probably be the first one to strap on a feed bag filled with Oak tree bark. Many other countries do not have an over viewing body, like the FDA, to make sure certain medication go through multiple studies to prove a medication can work on different diseases or ailments. The U.S. government is attempting to speed up the FDA approval process. As much as we all would like this, this may make the approval process less stringent where steps may be overlooked just to get a medication to market. Personally, I would rather wait a few years to make sure a product is safe before I take it as opposed to taking it and not knowing what exactly the side effects may be on my certain disease state. Even though a medication may be safe for human consumption for one issue, it may be contraindicated on people with other issues. I hope this helps and please keep me posted.
  9. trazadone

    Noah, To your first question, yes it is safe to take it an hour prior to bedtime. That is actually how I take it, but it all depends on how your Dr. told you to take it. If you were to switch the timing, I don't think it will be a big deal. As far as your second question I believe we taked about timing and keeping a journal. When to take a medication, how fast it works, and side effects are patient specific. The changing of the 25mg to one hour prior to bedtime may have made a difference. You can always try it by cutting in half the 50mg tablets you have. I also wanted to mention to you that the longer a person is on Melatonin the less effective it becomes. I know you have been on it a while so maybe trying to go without it may have no effect on how well or how effective it may be. I think at this time it is best to try one thing at a time. First try to take the 25mg one hour prior to bedtime for about three days. if that does not seem to be effective, then increase the dose to 50mg one hour prior to bedtime. If that seems to help, then you may want to think about eliminating the Melatonin. Sometimes when a medications becomes ineffective, people try a "drug holiday." I usually do not recommend this for prescription medications unless authorized by your Dr. In some circumstances being off of a medication, for as short as three day, and then going back on it can "reset" the bodies ability to process it which can make it more effective again. The reason I say to only change one thing at a time is that if you change more than one thing at a time, a patient or Dr. will have a hard time tell which change was positive and which one might have a negative effect on the body. I hope this helps and please keep me posted.
  10. I found this in the Israeli Medical Journal and wanted to pass it along to you #DiagnosticBreakthrough Israeli scientist develops early diagnostic test for Parkinson’s Suaad Abd-Elhadi’s new assay could pave the way for early diagnosis and improved treatment of the debilitating neurodegenerative disorder. By ISRAEL21c Staff AUGUST 3, 2017, 9:00 AM Photo of immunosorbent assay by Maltsev Semion/Shutterstock.com SHARE1,692 TWEET SHARE SHARE VIA WHATSAPP COMMENT EMAIL The exciting news coming out of Israel, that a scientist has developed a groundbreaking test to categorically detect Parkinson’s disease, is giving the medical and science worlds hope for the futureSuaad Abd-Elhadi, a PhD student at the Institute for Medical Research Israel-Canada in the Hebrew University of Jerusalem Faculty of Medicine, has developed the lipid ELISA diagnostic tool. She won the Kaye Innovation Award for 2017 for the breakthrough invention of this highly sensitive kit that may lead to earlier detection of Parkinson’s disease, along with better tracking of the disease’s progression and a patient’s response to therapy. Parkinson’s disease is the second most common neurodegenerative disorder in humans, after Alzheimer’s disease. It is typically characterized by changes in motor control such as tremors and shaking, but can also include non-motor symptoms, from the cognitive to the behavioral. An estimated seven to 10 million people worldwide are living with Parkinson’s disease, with medication costing approximately $2,500 a year, and therapeutic surgery costing up to $100,000 per patient. Making an accurate diagnosis of Parkinson’s, particularly in early stages and mild cases, is difficult, and there are currently no standard diagnostic tests other than clinical information provided by the patient and the findings of a neurological exam. Once Parkinson’s is revealed, the disease is usually already progressing. “Earlier diagnosis can help by seeing how a given drug affects the progress of the disease, for example,” Abd-Elhadi told Haaretz. “A big problem is that early PD looks just like other neurodegenerative diseases, which hinders appropriate care,” she explained. “A great deal of effort is presently being put into delaying the progress of PD, for which purpose one needs to know that one has it.” ELISA biomarker The global medical field has long noted that one of the best hopes for improving diagnosis is to develop a reliable test for identifying a biomarker — a substance whose presence would indicate the presence of the disease. In the case of the lipid ELISA, the cellular secretion of interest is a specific protein called alpha-synuclein. ELISA stands for “enzyme-linked immunosorbent assay.” An assay is a procedure used in laboratory settings to assess the presence, amount and activity of a target entity, such as a drug, cell or biochemical substance. ELISA is a common assay technique that involves targeting cellular secretions. The alpha-synuclein protein serves as a convenient biomarker that is closely associated with the tissues where Parkinson’s disease can be detected, along with the neurological pathways the disease travels along, causing its characteristic symptoms. Abd-Elahdi’s diagnostic tool can detect this specific protein. As a simple and highly sensitive diagnostic tool that can detect Parkinson’s biomarkers, the lipid ELISA could lead to a minimally invasive and cost-effective way to improve the lives of Parkinson’s patients, according to a Hebrew University statement. Abd-Elhadi has already demonstrated a proof of concept and is now in the process of analyzing a large cohort of samples, including moderate and severe Parkinson’s and control cases, as part of a clinical study. Through Yissum, its technology transfer company, the Hebrew University holds granted patents on the technology, and has signed an agreement with Integra Holdings for further development and commercialization. Abd-Elhadi is earning her doctorate in biochemistry and molecular biology. Under the supervision of Ronit Sharon, she conducts research that has been published in Scientific Reports and Analytical and Bioanalytical Chemistry.
  11. I thought this was a good FYI article. Business Chicago Tribune Are drug firms paying your doctor? Illinois doctors accepted $74.1M in industry payments last year In 2016, doctors in Illinois accepted more than $74 million from drug companies. (Getty Images) Lisa Schencker and Jennifer Smith RichardsContact ReporterChicago Tribune Lorenza Villegas doesn't think her doctors should accept free lunches or other types of payments from drug companies. But like most consumers, she hasn't looked up whether her physicians are among the many who receive money."I've got other things on my mind," said the East Garfield Park woman, 67, shortly after visiting Northwestern Memorial Hospital to make an appointment with her cardiologist. Many patients feel the same way about checking whether their doctors have taken payments from drug and device companies. It's been four years since the federal government started releasing data online detailing the financial relationships between doctors and drug- and device-makers. Many government officials and researchers have hailed the website, known as the Open Payments database, at openpaymentsdata.cms.gov, as a triumph of transparency. But it's unclear how much of a difference the data have made to patients or doctors. What's more, controversy remains over making the data public. Advocates say the information can help patients better understand their doctors' potential motivations for prescribing certain drugs, while critics say it can be misleading and raise suspicions about doctors who are truly working in their patients' best interests. More than 28,000 Illinois doctors accepted $74.1 million from pharmaceutical and medical device companies in 2016, excluding payments for research, according to a Tribune analysis of recently released federal data. Those payments were for travel, meals, consulting, speaking fees and royalties, among other things. Nationally, reported payments made to doctors have been slowly increasing. In Illinois, the numbers went down last year but are still higher than they were in 2014. But just because the data are available doesn't mean people are using it. In one yet-to-be published study, preliminary findings show only about 5 percent of patients surveyed last year knew whether their doctors had received payments. It's possible that even if people do know the data are publicly available online, "they don't seem to care sufficiently to look it up," said Genevieve Kanter, an assistant professor at the University of Pennsylvania who has studied the issue. The database, created under the Affordable Care Act, was intended to help prevent payments from swaying doctors' decisions. The federal government also encourages patients to use it to have conversations with their doctors about their financial ties to drug and device companies. Whether those things are actually happening is a matter of debate. The database has been a target of controversy since it first started. It's unclear whether the database will remain if the Affordable Care Act is repealed and replaced but at least one senator, Chuck Grassley, R-Iowa, has said he doesn't want to see the database weakened. Grassley, who co-wrote the part of the health care law creating the database, said in a statement last year, "With taxpayers and patients paying billions of dollars for prescription drugs and medical devices, and prices exploding, disclosure of company payments to doctors makes more sense than ever." The American Medical Association, however, has long criticized the accuracy of the data. Also, arguments continue over whether such payments are even a problem. "Some payments are part of legitimate research relationships, and some are made for promotional purposes," said Dr. Aaron Kesselheim, an associate professor of medicine at Brigham and Women's Hospital and Harvard Medical School in Boston who studies physician financial relationships and conflict-of-interest issues. In Illinois, the largest chunk of money received by doctors from industry — about 28 percent of payments excluding research, or $21.4 million — were for services such as serving as a speaker or faculty at a noncontinuing education event. Another 18 percent, $13.4 million, went toward consulting fees. Nearly 13 percent of the payments, about $9.5 million, were for food and drink, according to a federal analysis. Some find those numbers troubling. A number of studies over the years have shown that certain financial relationships can drive doctors to favor particular products when choosing medications for patients. "Drug reps do not see physicians unless they are affecting their prescribing, and pharmaceutical companies do not pay physicians unless they are affecting their prescribing," said Adriane Fugh-Berman, director of PharmedOut at Georgetown University Medical Center, a research and education project examining industry's effects on prescribing behavior. Drug companies and many physicians, however, contend the financial relationships are about educating doctors. Morry Smulevitz, a spokesman for North Chicago-based AbbVie, in a statement defended the payments the company makes to doctors: "Our interactions with health care professionals throughout the research and development process and in medical education bring value to patient care and are guided by openness and transparency." AbbVie last year paid more than 2,000 doctors in Illinois $1.6 million, the most of any Illinois company. Nationally, AbbVie made about 285,000 payments totaling nearly $35 million to hospitals and doctors last year. Many doctors also say the payments can help drive innovation and learning. Topping the list of Illinois doctors receiving general payments last year was Dr. Anthony Romeo, head of the section for shoulder and elbow surgery at Rush University Medical Centerand a team physician for the White Sox. Romeo received $1.75 million in general payments. But the vast majority of that money was from royalties and licensing. He's been designing and developing implants related to the care and treatment of shoulder and elbow conditions for more than 20 years and is prominent in his field. Most of the payments last year were from medical device company Arthrex. "The fact of the matter is the work I do and many people do in designing new tools and products is the way we innovate in health care so we can treat our patients better," Romeo said. The physician said he doesn't get compensated when he uses the devices on his own patients or when Rush uses them on patients. Romeo doesn't believe the database has made a difference since it was unveiled four years ago. "I think that a few people that abuse the system led to essentially government oversight that really I don't believe has changed anything with regard to this whole process," Romeo said. Kesselheim, at Harvard, said he believes the database has made a difference by increasing transparency and helping researchers investigate relationships between doctors and industry. Ideally, he said, the data could also spark conversations between patients and doctors about care. But little research exists on how many consumers actually use it. Kanter, the assistant professor at the University of Pennsylvania, published a paper this summer in the Journal of General Internal Medicine showing that before the data were first released in 2014, only 5 percent of patients surveyed knew whether their doctors had accepted payments. Kanter and her co-authors have since followed up on that study, again surveying patients last year. Preliminary results show the percentage of patients who knew last year whether their doctors had accepted money remained at 5 percent. It's possible that even when consumers know they can get the data, they don't look it up because they don't care or because they care about other factors more when choosing a doctor, Kanter said. Convenience, a patient's relationship with a doctor and insurance coverage may factor more heavily in a patient's decision-making than whether a doctor has accepted industry payments. Some patients may even like that doctors receive payments from drug or device companies. A 2014 study published in Journal of Law, Medicine and Ethics found that doctors who received no payments were often viewed by patients as virtuous but also inexperienced or professionally isolated. It's also possible that patients don't look up data about their doctors because they don't know what to do with the information, Kanter said. Should they talk to their doctors? Switch physicians? Ignore it? "They may be confused about how they should interpret this information or how they should understand this issue," Kanter said. "Even among researchers, there is debate about what it really means in terms of physician behavior." PharmedOut's Fugh-Berman believes that patients with doctors who accept industry payments should change physicians. "Any doctor who's seeing drug reps or being paid by any companies is going to have less accurate information about drugs in general than physicians who don't," she said. "Drug reps are trained to deliver messages in a way that advantages their products." Others, however, suggest a less black-and-white approach. If patients are concerned by what they find on the database, they can ask their doctor about it, said Dr. Aaron Mitchell, an oncology fellow at the University of North Carolina who has studied how payments influence prescribing behavior. "It's definitely worthy of a conversation if a patient is concerned," Mitchell said. "Within a lot of these subspecialty fields it can be difficult to find a doctor that doesn't have some level of relationship (with industry). It's pretty prevalent." Many patients, however, aren't terribly concerned. Shortly after visiting a specialist at Northwestern on a recent day, Miroslava Arias said she's heard of the issue and should look up her doctors online to see if they've received payments. But when the 50-year-old Joliet woman visits her physicians, she said her main thought is, "Just try to fix me." lschencker@chicagotribune.com jrichards@chicagotribune.com Twitter @lschencker Twitter @jsmithrichards Copyright © 2017, Chicago Tribune
  12. WORLD South China Morning Post Parkinson’s breakthrough as stem cells restore mobility in monkeys, with human trials coming soon Lab monkeys with Parkinson’s symptoms regained significant mobility after neurons made from human stem cells were inserted into their brains, researchers reported Wednesday in a study hailed as “groundbreaking”. The promising results were presented as the last step before human clinical trials, perhaps as early as next year, said the study’s senior author, Jun Takahashi, a professor at Kyoto University. Parkinson’s is a degenerative disease that erodes motor functions. Typical symptoms include shaking, rigidity and difficulty walking. In advanced stages, depression, anxiety and dementia are also common. Worldwide, about 10 million people are afflicted with the disease, according to the Parkinson’s Disease Foundation. Earlier experiments had shown improvements in patients treated with stem cells taken from human foetal tissue and likewise coaxed into the dopamine-producing brain cells that are attacked by Parkinson’s. Dopamine is a naturally occurring chemical that plays several key roles in the brain and body. But the use of foetal tissue is fraught with practical and ethical problems. They became more active, moving more rapidly and more smoothly JUN TAKAHASHI DESCRIBES HIS TREATMENT OF MONKEYS WITH PARKINSON’S SYMPTONS So Takahashi and his colleagues, in a medical first, substituted so-called induced pluripotent stem cells (iPSCs), which can be easily made from human skin or blood. Within a year, some monkey’s who had could barely stand up gradually recovered mobility. “They became more active, moving more rapidly and more smoothly,” Takahashi said by email. Animals that had taken to just sitting “start walking around in the cage.” “These findings are strong evidence that human iPSC-derived dopaminergic neurons can be clinically applicable to treat Parkinson’s patients,” he said. Experts not involved in the research described the results as encouraging. The treatment, if proven viable, “has the potential to reverse Parkinson’s by replacing the dopamine cells that have been lost - a groundbreaking feat,” said David Dexter, deputy research director at Parkinson’s UK. “Not only did the new cells survive... but they also integrated with the existing neuronal network,” he said. Neurons made from foetal tissue grafted into brains have been known to survive for more than a decade, and the researchers said they expected those derived from iPSCs to last just as long. Tilo Kunath, Parkinson’s Senior Research Fellow at the University of Edinburgh, said the outcome was “extremely promising,” and highlighted the advantage of avoiding stem cells extracted from human foetal tissue. “It means that this therapy can be used in any country worldwide,” including Ireland and most of South America, where medical use of human embryonic stem cells is banned. The results, reported in the journal Nature, were not the same for the dozen monkeys in the experiment, each of which received donor neurons from a different person. “Some were made with cells from healthy donors, while others were made from Parkinson’s disease patients,” said lead author Tetsuhiro Kikuchi, also from Kyoto University. The varying outcomes suggested that the quality of the donor cells might play a role, so the researchers looked for genes that might explain the differences. Eleven genes, especially one known as Dlk1, showed up in many of the most successful transplants, suggesting that screening potential donor cells may be critical. Other experts evaluating the study said that stem cell treatment targets only some symptoms. “No one expects that transplants will address the non-dopamine, non-movement aspects of Parkinson’s disease, such as dementia and falls,” said Tom Foltynie, a professor at the National Hospital for Neurology and Neurosurgery in London. In the experiments, the lab-made nerve cells were injected into the brain through a thin needle during surgery. “The needle is so thin that it causes almost no damage,” Takahashi said. In a companion study, published in Nature Communications, scientists from Takahashi’s laboratory tested ways to avoid rejection of implanted neuron cells. After organ transplants or skin grafts from donors, recipients must take drugs to prevent their immune system from attacking foreign tissue. In monkey-to-monkey experiments, they found that the neuron transplants worked better across animals who shared similar gene groups responsible for shaping the immune system. The same, they conjecture, will apply to humans. In addition, if the stem cells came from the patient’s own skin or blood, the problem would probably not arise in the first place, Takahashi said.
  13. New medication for PD Dyskensia, per Drugs.com

    Yes, if someone is taking amantadine 100mg three times a day, this would be a substitute for that. Instead of taking 3 regular amantadine a day, you would only have to take one of the new medication at nighttime. I hope this helps and please keep me posted.
  14. Approves Gocovri FDA Approves Gocovri (amantadine) for the Treatment of Dyskinesia in Parkinson's Disease Patients EMERYVILLE, Calif., Aug. 24, 2017 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced that the U.S. Food and Drug Administration (FDA) has approved Gocovri (amantadine) extended release capsules (previously ADS-5102) for treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. Gocovri, previously granted orphan drug status by the FDA, is the first and only medicine approved by the FDA for this indication. "Gocovri's approval is an important advancement for the treatment of Parkinson's disease, as it is the first FDA-approved medicine for the treatment of dyskinesia in Parkinson's disease patients," said Rajesh Pahwa, M.D., Laverne & Joyce Rider Professor of Neurology at the Kansas Medical Center and Director, Parkinson's Disease Center of Excellence at the University of Kansas Health System. "Notably, Gocovri is the first Parkinson's disease medicine proven in controlled trials to reduce both dyskinesia and OFF time in Parkinson's disease patients receiving levodopa. Treatment of dyskinesia and OFF time continues to be an unmet need in the medical management of Parkinson's disease and the approval of Gocovri is a major step in that direction." Gocovri is a high dose 274 mg amantadine (equivalent to 340 mg amantadine HCl) taken once-daily at bedtime that delivers consistently high levels of amantadine from the morning and throughout the day when dyskinesia occurs. Dyskinesia is a consequence of levodopa-based Parkinson's disease treatment and is characterized by involuntary and non-rhythmic movements that are purposeless and unpredictable, which impact the activities of daily living. "Dyskinesia can significantly compromise quality of life for people with Parkinson's disease," said Dr. Todd Sherer, Chief Executive Officer of The Michael J. Fox Foundation for Parkinson's Research. "We are pleased that patients have another option to manage this aspect of the disease and glad the Unified Dyskinesia Rating Scale - a tool our support helped develop and validate - could show clinical efficacy of Gocovri for the treatment of dyskinesia." Gocovri's positive benefit/safety profile was established in two Phase 3 controlled clinical trials in Parkinson's disease patients with dyskinesia. In Study 1, patients treated with Gocovri demonstrated statistically significant and clinically relevant reductions in dyskinesia, with a 37 percent reduction in Unified Dyskinesia Rating Scale (UDysRS) total score vs. 12 percent for placebo at Week 12. These results were confirmed in Study 2 in which Gocovri achieved a 46 percent reduction in UDysRS vs. 16 percent for placebo. Additionally, key secondary data from Parkinson's disease patient reported diaries in Study 1 and Study 2 respectively, showed that Gocovri-treated patients experienced a 3.6 and 4.0 hour increase in functional time daily (defined as ON time without troublesome dyskinesia) vs. a 0.8 and 2.1 hour increase for placebo-treated patients at Week 12. The increases in functional time were achieved by decreases in both ON time with troublesome dyskinesia and OFF time. The placebo-adjusted reduction in OFF time in both studies was approximately 1 hour per day. The most commonly observed adverse reactions ( > 10 percent and greater than placebo) with Gocovri were hallucinations, dizziness, dry mouth, peripheral edema, constipation, fall and orthostatic hypotension. For additional Important Safety Information, see below. "Today's approval is a tremendous milestone for Adamas and for the Parkinson's disease community," said Gregory T. Went, Ph.D., Founder, Chairman and Chief Executive Officer of Adamas Pharmaceuticals, Inc. "Gocovri has the potential to help people with Parkinson's disease suffering from dyskinesia by finally providing physicians with an effective tool to address this long-standing unmet medical need. We thank the physicians, clinical staff, patients and their families who participated in the clinical trials for making this advancement possible for the community." Gocovri is expected to be available in the fourth quarter, and formally launched with the full deployment of Adamas's sales force in January 2018. Adamas developed Gocovri for people with Parkinson's disease and the company is committed to helping them gain access. Adamas has created "Gocovri Onboard," a patient services program, which will facilitate access and distribution. "Gocovri Onboard" will work with patients, their families and physicians to obtain access to Gocovri via reimbursement support, prescription fulfillment and financial assistance. "Gocovri Onboard" is designed to deliver dedicated assistance and financial support to patients in need. About Parkinson's Disease and Dyskinesia Parkinson's disease is a chronic neurodegenerative disorder affecting close to one million people in the U.S. Parkinson's disease results from a loss of dopamine in the brain and is commonly treated by levodopa and dopaminergic therapies that help replace lost dopamine. As the disease progresses, people require increasingly higher or more frequent doses of levodopa in order to avoid the recurrent periods of OFF time - characterized by slowness of movement, rigidity, impaired walking, tremor and postural instability - when the underlying symptoms of Parkinson's disease return. Over time, nearly 90 percent of people on levodopa therapy experience dyskinesia, which is characterized by involuntary and non-rhythmic movements during waking hours that are purposeless and unpredictable. Dyskinesia can interfere with people's daily living, resulting in functional impairment and disability. People with Parkinson's disease often experience multiple fluctuating periods of OFF time and dyskinesia during any given day, which can impede their movement and daily function. In the U.S., there are approximately 150,000 - 200,000 people with Parkinson's disease whose daily life is impacted by dyskinesia. Until now, physicians have had limited options to manage, and have had no approved medicines to treat dyskinesia. About Gocovri Gocovri is the first and only medicine approved by the FDA for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. Gocovri is a high-dose 274 mg amantadine taken once-daily at bedtime, which delivers consistently high levels of amantadine in the morning and throughout the day when dyskinesia is most prevalent. Gocovri has received orphan drug status from the FDA. For more information about Gocovri, including the full Prescribing Information, please call 1-844-GOCOVRI [1-844-462-6874] or visit www.GOCOVRI.com. About Adamas Pharmaceuticals, Inc. At Adamas, we believe in the power and the promise of medicines derived from a deep understanding of time-dependent biology. Our expertise lies in uncovering and mapping the relationship between disease and drug activity. From there, we strive to create medicines with therapeutic profiles that match the pattern of disease to drive a more significant and durable clinical effect. This understanding of time-dependent biological processes informs our every innovation, targeting advancement in treatment of chronic neurologic disorders. Our portfolio includes: Gocovri™ (amantadine) extended release capsules (previously ADS-5102), the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications; ADS-5102 in development for the treatment of multiple sclerosis walking impairment and additional indications in Parkinson's disease, and ADS-4101, a high-dose, modified-release lacosamide in Phase 1 clinical development for the treatment of partial onset seizures in patients with epilepsy. Additionally, Adamas's licensed assets are currently marketed by Allergan under the brand names NAMENDA XR® and NAMZARIC®, and Adamas is eligible to receive royalties on sales of these medicines beginning in June 2018 and May 2020, respectively. For more information, please visit www.adamaspharma.com. NAMENDA XR® and NAMZARIC® are trademarks of Merz Pharma GmbH & Co. KGaA. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Gocovri is contraindicated in patients with creatinine clearance below 15 mL/min/1.73 m2. WARNINGS AND PRECAUTIONS Falling Asleep During Activities of Daily Living and Somnolence: Patients treated with Parkinson's disease medications have reported falling asleep during activities of daily living. If a patient develops daytime sleepiness during activities that require full attention (e.g., driving a motor vehicle, conversations, eating), Gocovri should ordinarily be discontinued or the patient should be advised to avoid potentially dangerous activities. Suicidality and Depression: Monitor patients for depression, including suicidal ideation or behavior. Prescribers should consider whether the benefits outweigh the risks of treatment with Gocovri in patients with a history of suicidality or depression. Hallucinations/Psychotic Behavior: Patients with a major psychotic disorder should ordinarily not be treated with Gocovri because of the risk of exacerbating psychosis. Observe patients for the occurrence of hallucinations throughout treatment, especially at initiation and after dose increases. Dizziness and Orthostatic Hypotension: Monitor patients for dizziness and orthostatic hypotension, especially after starting Gocovri or increasing the dose. Withdrawal-Emergent Hyperpyrexia and Confusion:Rapid dose reduction or abrupt discontinuation of Gocovri, may cause an increase in the symptoms of Parkinson's disease or cause delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression, or slurred speech. Avoid sudden discontinuation of Gocovri. Impulse Control/Compulsive Behaviors: Patients may experience urges (e.g., gambling, sexual, money spending, binge eating) and the inability to control them. It is important for prescribers to ask patients or their caregivers about the development of new or increased urges. Consider dose reduction or stopping medications. ADVERSE REACTIONS The most common adverse reactions ( > 10%) were hallucination, dizziness, dry mouth, peripheral edema, constipation, fall, and orthostatic hypotension. DRUG INTERACTIONS Other Anticholinergic Drugs: The dose of Gocovri should be reduced if atropine-like effects are observed. Drugs Affecting Urinary pH: The pH of the urine has been reported to influence the excretion rate of amantadine. Monitor for efficacy or adverse reactions under conditions that alter the urine pH. Alcohol: Concomitant use with alcohol is not recommended, as it may increase the potential for CNS effects such as dizziness, confusion, lightheadedness, and orthostatic hypotension. Forward-looking Statements Statements contained in this press release regarding expected future events are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to, statements contained in this press release regarding the expected benefits of Gocovri, physician and patient access in fourth quarter 2017 and launch of Gocovri (amantadine) extended release capsules (previously ADS-5102) in January 2018 for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, and Adamas' plans to offer a number of programs providing patient access support throughout the course of treatment, along with commercial copay assistance and financial assistance for patients who are uninsured or underinsured. Words such as "potentially," "expected," "will," "plans" and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. For a description of risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, including risks relating to Adamas' research, clinical, development, and commercial activities relating to ADS-5102 and ADS-4101, and the regulatory and competitive environment and Adamas' business in general, see Adamas' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 8, 2017. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Adamas undertakes no obligation to update any forward-looking statement in this press release. Source: Adamas Pharmaceuticals, Inc. Posted: August 2017 Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Data sources include Micromedex® (updated Aug 2nd, 2017), Cerner Multum™ (updated Aug 2nd, 2017), Wolters Kluwer™ (updated July 5th, 2017) and others. To view content sources and attributions, please refer to our editorial Copyright © 2000-2017 Drugs.com. All rights reserved.
  15. New medication for PD Dyskensia, per Drugs.com

    Noah, Right now there are a few new medications in the pipe line, but they are either not in the trial phase or are in stage one trial phase , which means there is very little known about them. I will try to gather some information about those and post it. As far as how Gocovri is different from regular amantadine is: - Gocovri is a sustained release product that is just a once a day dose (at night) that contains and equivalent of 340mg of regular amantadine - Regular amantadine is 100mg which is usually taken 2 to 3 times daily. Basically you will have better patient compliance with only having to take it once a day AND is only indicated for dyskensia due to Parkinson's Disease. I hope this helps and please keep me posted.
  16. Possible Sinemet side effect?

    Lalita, What you will want to stay away from are medications with Carbidopa/Levodopa in the, like Stalevo and Rytary. I believe the next choice and possibility could be a dopamine agonist like Requip or Mirapex. I prefer Requip because I have seen less side effects with it, even though they are in the same drug class. As far as the Brand Name Sinemet, the side effect profile would be the same as the generic medications for it. When people may use the words "works better" I usually take that as they may be getting better results than what they may have received with a generic. I have taken both, the brand and generic, and have found out that the Mylan brand of the generic works best for me. The CR has the longest duration of action for me and the regular release has the best onset of action and duration for me. I hope this helps and please keep me posted.
  17. On Vacation

    I agree about the influence of peers. I have involved them in many organizations and events to help out the less fortunate or people in need. To them I am just "Dad,' not a dad with Parkinson's. But we do go to the Unity Walk in New York every year, which they enjoy. They have both lead their classes in community service awards every year, which to me is better than an "A" in any class. I believe we have instilled the correct morals so that they both become leaders and not just followers, and also to look out and help others who cannot look out for themselves. Thank you for the jolt of confidence. I know there may be bumps along the way, but I know we have prepared them well. Mark
  18. On Vacation

    Hello everyone, I will be on vacation moving my daughter to college. I will be able to start answering questions on Wednesday August 24tg. Thank you for understanding, Mark
  19. trazadone

    Noah, It is hard to tell exactly when one person will feel the effects compared to others. I usually give it an average of 2 weeks to see the full effects. It is also difficult to see the effects that one medication has when you are taking more than one for the same issue. I know you are taking Melatonin and Valerian, so trying to adjust the timing of those along with the Trazadone may be tricky and could call for some trial and error. I also think other factors can help as well. 1) Have a bedtime routine. Ie. Eat dinner, go for a walk, shower, watch TV, brush your teeth, then go to bed. It is very important to get as much activity during the day to make you tired at night. The less you do during the day, the more difficult it is for you to sleep at night. 2) Trying to go to bed at the same time every night. 3) not eating a big meal before bedtime. Only snacks with low sugar. 4) Avoid "blue light." Ie. Computer's, laptops, tablets, and cell phones. 5) If you watch TV before bed, make sure you limit it to one or two episodes then shut it off. If you have the option of your TV to have it shut off at a certain time, make sure you set it. Many times people will keep it on and fall asleep, then wake up a few hours later with the TV still running, and this will peak their interest to watch or to go through the hassle to shut it off. Just those few seconds to turn it off can stop the sleep cycle you are in. 6) Avoid television or reading that makes you think to much. This can actually keep your brain thinking while trying to sleep. 7) Try the 4-7-8 breathing technique. This has worked well for me because it brings my mind to the "here and now" while I am thinking about breathing and puts all the other stuff in the background. The technique is to inhale for a count of 4, hold the breath for a count of 7, and exhale for a count of 8. This is also used in meditation. It slows the heart rate, reduces anxiety, and actually changes the brain waves. The most important part is to focus on the counting, which should then push all the other thoughts that cause a "running mind" to the background. I hope this helps and please keep me posted.
  20. On Vacation

    Otolorin, I did have a great time. I knew this day was coming, but did not realize how quickly it got here. She is a great kid and I know we have instilled great morals and values in her. But, like I told her, now is the time for her to apply them for herself. Thanks for checking in.
  21. Sinemet CR spacing

    It may cause dyskensia soon after you take the lunch time doubled dose because you are doubling the dose. More than likely you may not notice any side effect, i just wanted to make you aware that there is a possibility that it may occur. I hope this helps and please keep me posted.
  22. DBS Evaluation Requirements

    Queenie, I totally agree with you that it is scary to stop your meds, especially an agonist, cold turkey. I would worry if you were only on an agonist. Since you are also on carb/levo, it will be less of an issue. I don't want to say it will be easy, but in order for the Dr's to evaluate you probably, they will need to see you at your worst without your medications. I hope this helps and please keep me posted.
  23. nausea from sinemet

    There are a couple things you could try. One is a product called Lodosyn. It is pure carbidopa. Carbidopa was originally added to levodopa to limit the nausea related to levodopa. Lodosyn can be prescribed by your Dr and in no way will interfere with the effectiveness of the levodopa. The other option may be to eat something small, like crackers, popcorn, etc... something light. This should have little effect on the absorption is the medications, as long as it is not protein. I hope this helps and please keep me posted.
  24. On Vacation

    Linda, I had a great time ,but it was bittersweet. It is my eldest daughter who went away, but I still have my 14 year old daughter to keep me busy. I know we have given her the tools to make sound decisions, just like my parents did with me. I was the first person in my blood relation family to go to school. Talk about pressure. I told her that college isblike no other experience in the world. You will meet people from all over the world who may have the same or different beliefs as you. No matter what, you can learn from anyone and if you show respect, you will get respect in return. I did tell her the most important things to keep in mind are to have fun and absorb all that you can. Thanks for asking.