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Found 62 results

  1. I was formally diagnosed in 2011. Shortly after this occurred, because I have a 40 year background in natural medicine, I started to try various natural protocols that had been shown to be effective for some people with Parkinson's. One of the first approaches I tried was Mucuna. Within a month, I dropped this approach because it seemed to be doing nothing for me. Little did I know that it would not be many years before I found out that virtually all the Mucuna supplements in the states contained usually no more than 15-18% L-Dopa. This information made it easier to understand why I had experienced no success with it. In 2016, I was contacted by a friend with Parkinson's who lives in Europe and had been taking Mucuna extract that was 98 - 99% L-Dopa. Roughly 3.5 years ago, I became so dysfunctional due to the symptoms of Parkinson's that I became almost bedridden for 2.5 years and 100% dependent on my wife for all daily activities. I took Mucuna extract at the 2.5 year point of being stuck in bed and in less than a week, I was out of bed and 98% independent. I will say that again... In less than a week, I was out of bed and 98% independent. I started with 250 milligrams 4 x/day. Now, 1 year later, I take between 800 -1,000 milligrams 5x/day and have been using that dosage for approximately 6 months. Here's my concern... There is much information online that states that long term use of Mucuna is safe. However, it is clear that the substance used in all of that exploration was the whole herb. I have not been able to find any information regarding long term use of Mucuna EXTRACT. ANY HELP WITH THIS EXPLORATION WOULD BE DEEPLY APPRECIATED! This month I am starting a kind of an "alchemical" experiment. I have placed one pound of Mucuna whole herb from Banyan Botanicals into a gallon jar and have filled it with the highest quality Vodka I could find here. I am not able to get grain alcohol where I live. I have placed the jar in a dark cupboard and am shaking it vigorously each day. After roughly three weeks, I will add my Mucuna whole herb "tonic" to the Mucuna extract each time I take it.
  2. Buzka

    I started taking Sinemet 100/25 twice daily a year ago when I was diagnosed with Patkinson's diseases. After a few months I started to get blisters on my legs, some of them quite large, ie approx I cm in size. As I do not take any other medication I can only assume that it's a side effect of Sinemet. There doesn't appear to be any evidence to back my theory. I would therefore like to hear from anyone who has similar experiences.
  3. Trying Sinemet

    I'm now over 4 years since diagnosis. Exercise has been my primary medication for these past 4 years. About a year ago, my tremors were significant enough that people frequently asked what was wrong with me. The tremors made me look weak (sick), which is simply not acceptable to me. I began taking medical marijuana about a year ago and was very satisfied with the result. Not only did it improve the tremor, but it also virtually eliminated my frequent urination/urgency issue; lessened my fatigue; improved my sleep, and much more. All this improvement without side effects. Unfortunately, as time went on, I discovered several problems with using medical marijuana as the primary PD drug. None of these problems were related to medical issues, but rather legal and other practical issues. I discussed this in a recent post. Therefore, at my last MDS appointment, I discussed these issues with my MDS. He recommended trying Rimantadine. It had plenty of side effects but no effect on my tremor. He suggested trying Sinemet, which I am now doing. I'm taking one 25/100 tablet 3 times a day. One at 6:30 am. One at 11am. One at 4 pm. I was hesitant to carry medical marijuana in my vehicle and therefore often didn't take my medication on a very good schedule. With Sinemet, I can obviously keep Sinemet in my vehicle and therefore take my medication on a better schedule. The only significant side effects I've noticed with the Sinemet are nausea and vivid dreams (including nightmares). Sinemet does a surprisingly good job on my tremors, but doesn't do anything for my frequent urination/urgency issue. I also am not sleeping quite as well with Sinemet as with the MM. In summary, I believe that medical marijuana is the better drug. However, due to the legal and practical issues with marijuana, I am planning to reluctantly stick with Sinemet, at least for the foreseeable future.
  4. I was diagnosed with T1 Diabetes in 2008 (I was 49 at the time) and about 3 months ago started Sinemet for PD. In the past month or so my Blood Glucose and/or insulin resistance have spiked up until about 12:00 noon. I've read some research regarding Sinemet's possible influence on what's happening. Neither my Endocrinologist nor my Neurologist has sufficient experience in each others field to know what's going on. Any ideas here so I know if this is a new paradigm where I need to permanently adjust my insulin dosage? I'm also taking 60mg of Cymbalta and 30mg of Remeron, as well as Synthroid for Hashimoto.
  5. Hi everyone I've been lurking in the shadows here for a while and I have an exercise question that I can't find much of an answer for. First the question, then I'll give my background info for context. Everyone says exercise is a must for PD, yet I find that when I exercise, my symptoms get much worse for several hours, before returning to baseline. Though I recognize that in the long term it may help, it's hard to motivate myself to get off the couch when I know I will feel like heck after. This applies to any type of exercise, including just a busy day running errands etc. I have found that I can limit the impact slightly by being aggressive with my sinemet dosing, but I haven't found a good "formula" yet. My question is twofold - is this normal for people with PD, and if so, how do you manage the issue? Now my background. I'm 34, diagnosed 6 months ago, though I was suspicious of PD about a year before that. Much of that 1 yr delay was because my DAT came back normal and first neuro concluded it was likely just 'in my head'. Long story short I found another neruo, ironically not an MDS like my first one, and he made the diagnosis and started sinemet (due to problems with ICD's I can't be on the DA's nor Rasagiline, learned the hard way). Initially I was on 3 X 100/25 immediate daily, but symptom control was not great and it did not last long enough to get me from dose to dose. I also had some mild 'diphasic' type dyskinesias (so much for 5 years, I was dyskinesia free for 1 month . By 'mild' I mean it didn't keep me from doing anything but people would sometimes stare at me. Anyway my neuro upped the dose to 6 X 100/25 daily and after some experimenting I settled on the same dose but with a schedule of 4 X 1.5 pills instead of 6 X 1 pill. Currently my symptoms are well controlled through the day and dyskinesias nearly gone, though the evenings are a bit tough sometimes. But enough about me, what does exercise do for you (or to you ? -Ed
  6. Too much meds

    What happens if you take too much C/L? How does it make you feel or affect you?
  7. Fifty-nine year old male with a fairly recent "probable" diagnosis of PD by an MDS after having a right hand/arm tremor (my only symptom) for almost ten months. Tried Propranolol (20mg, 1x daily), then Trihexyphendidyl (2mg, 1x daily), then Amantadine (100mg, 3x daily) with none affecting my tremor. In a previous post of mine on this forum where I asked you about Amantadine's effectiveness, you kindly responded the above meds were not optimum for treating tremor. You said Sinemet or a dopamine agonist would be better. Early this week in my follow-up visit, my MDS did prescribe Carbidopa/Levodopa (25-100mg, 3x daily) and stopped the Amantadine. How long is typical before I might notice a difference in my tremor? 1 week? 2 weeks? 1 month? I've read on this forum where some patients experience an almost immediate effect, but it looks like the length of time before it starts affecting tremors varies quite a bit, too. I'm just trying to set a reasonable expectation in my mind for the time frame before, hopefully, I see an improvement in my tremor. I have a follow-up MDS appointment in six weeks. Thank you for your time and commitment to helping people in this forum.
  8. Hi Everyone, I am new to this forum, though have been referencing it for years. My dad has Parkinsons, is in about his 12th year or so of the disease, maybe longer. I am so sorry to everyone out there who is so frustrated and disabled by this disease. It is so hard. My family is trying to figure out his dosing schedule. Any input would be tremendously helpful and appreciated. I know a lot of it is trial and error. I have always wondered if his other pills make the Parkinson's medicine less effective. Additionally, he wakes CONTINUALLY in the night shaking violently. This has become a terrible problem as he wakes up every hour. My dad has an Essential Tremor in addition to Parkinson's. He has had this since his early teens, he is now 70. His current pill schedule: -Carbidopa 25 mg-levodopa 100 mg tablet. Currently, my mom is trying: 1 pill at 7am 1 pill at 10:30am 1 1/2 pills at 1:30pm 2 pills at 4:30pm 2 pills at 7:30pm 1 pill at 10:00pm 1 extended release at 11pm right before bed -For his Essential Tremor he takes Primidone 50mg a day and Propranolol 320mg a day extended release. -For a mild A-fib, he takes Warfarin 5mg (1 1/2 on M,W,F. 1 on S, S, T, Thurs.) -The rest of these pills I'm assuming are blood pressure from what I can figure out triamterene 37.5 mg-hydrochlorothiazide 25 mg tablet, 1 tablet daily K-Tab 10 mEq tablet, extended release, 1 tablet daily Losartan 100 mg tablet, 1 tablet daily Amlodipine 5 mg tablet, 1 tablet daily Vitamin D2 5,000, 1 tablet daily My dad does do a recumbent for 5-10 minutes a day and knows to try not to eat protein with his pills. I would sincerely appreciate any advice, suggestions or tips on this schedule. Thank you so very much, Amy
  9. My mom is 74 years old. She was diagnosed with Parkinson's 9 years ago. She was taking 3 different medications Sinemet, Neupro patch, and Amantadine. She was having horrible edema in her feet and ankles. The Parkinson's symptoms weren't bad at this point. Because of the swelling the doctor decided to take her off of the Amantadine since that can cause swelling. When she eliminated that medication the swelling didn't go down but the muscle spasms in her face, causing her to stutter went away, which was good. She is still off the Amantadine. So the doctor decided to take her off the Neupro patch. That did it.....all the swelling is gone. But the bad news, all those Parkinson's symptoms that weren't so bad got a whole lot worse. For starters, she is a lot weaker and moves a lot slower. She is down to one medication, she only takes a half a sinemet pill 5 times daily. Anything more than that makes her really nauseous. She is very little anyway 5'2 and 90 pounds and is obviously very sensitive to medications. Ever since going down to one medication, she has terrible anxiety, some depression and her blood pressure either gets too high or too low. She is taking blood pressure medicine to treat that symptom. I'm just wondering if all this anxiety, depression and blood pressure problems have to do with "off" times because her sinemet isn't lasting long enough. She is reluctant to go on another medication because of the side effects like nausea and edema. Just wondering if anyone else has had these problems and what medications work best for them.
  10. Medications and Early PD

    My drug regimen for the 3 years since my PD dx has been Ropinirole 3mg twice a day and 2 mg once a day for a total of 8 mg a day and Amantadine 100 mg twice a day. My PD symptoms are mild, mainly stiffness and slowness, with no significant tremor. I take a variety of exercise classes every week including low impact Zumba, tai chi, and yoga. My stiffness was causing me to feel about as flexible as a tree trunk as my shoulders and hips just didn’t want to move. Cuban motion went out the window. So in January I told my Movement Disorder Neurologist that I was ready to try Sinemet to see if it would help with my flexibility. (He had been recommending this but I was previously hesitant and felt I didn't need it.) I’m now taking Sinemet 25/100 and have been titrating up for the past 6 weeks and have reached one pill three times a day. I’m also still taking the same doses of Ropinirole and Amantadine. I am starting to notice more flexibility in my shoulders and hips and my walking gait and arm swing have improved. Other people have also noticed improvement, so it looks like the Sinemet is making a difference. My neurologist said it would be okay to continue taking all 3 drugs – but I’m wondering if I really need all three, especially the Ropinirole. I’ve tried stopping the Amantadine before and I started feeling worse in a general way with more weakness on the right side. I just don’t want to take more medication than I need. I’m fortunate that I haven’t had any significant side effects – some temporary drowsiness from the Ropinirole and occasional temporary edema from the Amantadine. I’m taking the 3 doses of Ropinirole in-between the 3 doses of Sinemet. and Amantadine at the same time as the first two doses of Sinemet. I know Sinemet has a very short half life and Ropinirole has a much longer half life. I really don’t experience any noticeable “off” times. However I’ve read that researchers think the cause of dyskinesia may be the constant highs and lows caused by the Sinemet. So my questions are: 1. Does staggering the doses of Sinemet and Ropinirole increase the length of time I should feel the benefits of the dopaminergic effects? 2. Will continuing both Ropinirole and Sinemet flatten the highs and lows between doses of Sinemet? 3. Does taking both Sinemet and Ropinirole increase the likelihood of developing dyskensia’s sooner? 4. Is continuing on all 3 drugs recommended if there are no side effects? Thank you for your input - and I've ready both your books and highly recommend them to others as they are informative and easy to read.
  11. My mom is 74 years old and was diagnosed with PD 9 years ago. Recently she was on Sinemet, Neupro, and Amantadine. Her PD symptoms were minimal, but she was having severe edema in her feet and ankles. The doctor took her off of the Amantadine, and the swelling was still there, but the muscle spasms she was having went away so she never went back on the Amantadine. The doctor then took her off of the Neupro patch, and that did it, no more edema in her legs. Having gone off two PD medications her PD symptoms are now a lot worse. She has a lot of anxiety and spikes her in her blood pressure throughout the day. She is on two different blood pressure medications, plus clonidine to help with bringing the BP down immediately. And she takes clonazepam to help with the anxiety. She takes a half a pill of sinemet 5 times a day. This is the only PD medication she is on right now. If she takes a whole pill or takes it any more than 5 times a day she says she is nauseous. I'm assuming the blood pressure and anxiety has to do with not getting enough sinemet? What do we do to get the sinemet to last longer without all the nausea? Is there another medication she can take that won't interact with her other medications or make her nauseous? She has taken azilect before without any problems but I am afraid it might make her too drowsy with the anxiety medication. Any help would be appreciated. Thanks. Tricia
  12. Nausea with Sinemet

    Hi Mark My mom was diagnosed with Parkinson's 9 year ago, she is now 74. She was on Sinemet, Neupro, and Amantadine, but the doctor took her off the Neupro and Amantadine because of serious edema she was having in her feet and ankles. She is now only on the Sinemet. You can imagine going off that much Parkinson's medicine has made the Parkinson's symptoms much worse. She is a lot weaker and has a lot of anxiety where she didn't have any anxiety before (she takes Klonopin for the anxiety). I think all of this is because she is on the minimum amount of medication and has more "off " times than "on" times. She only takes a half a pill of sinemet 5 times a day. If she takes a whole pill it makes her really nauseous. She takes it with food but that doesn't seem to help. Is there anything she can take to help with the nausea? I'm not sure if changing to an exended release would help the nausea or make it worse. Any advice you can give me would be greatly appreciated. Thanks, Tricia
  13. Is it time for DBS?

    I am 60 years old, 6'9", 220 lbs and was diagnosed with Parkinsons in August, 2010. My first visible symptom was a tremor in my right thumb in 2006. Today my main symptom is my tremor which can be seen at: I currently take 2 tablets of 25/100 Carb/Levodopa every 2 and one half hours starting at 6am with my last dose at 6:30pm. I take an extended release 50/200 when I go to bed. I also take 2mg Ropinirole three times per day. When I wake up at 6am I walk with a shuffle and feel in a daze,a little stiff, and my hand tremors. This can last from 30 to 60 minutes, then I feel good with no visible symptoms. I eat breakfast then. Most mornings I have a period of tremoring as seen on the video for about 15 minutes and can be as long as an hour. The same thing happens later in the afternoon. At around 9pm I feel like I am in a daze and will tremor again. My arm feels stiff and I feel in a daze again. If I wake in the middle of the night, my hand will tremor. I was told by a movement disorder specialist in September, 2014 that I needed to have DBS within six months, but I felt that I was responding well to the medications (9 tablets per day then) so why the urgency to have risky brain surgery. My Parkinsons has progressed. I have increased my meds and taking 13 tablets carb/levo per day plus the extended release. I do not have any dyskinesias. I have been told that the recommend max dosage per day is 1200mg, but perhaps I can tolerate more because of my size. Should I increase meds and hold off on brain surgery in hope of some less invasive treatment? I have read about the ultrasonic treatment, but that does kill cells. Perhaps another drug like Rytary? Sorry for the long post. Any comments would be appreciated. Thanks.
  14. High Blood Pressure

    Good Day, My mother (79 years old) has been treated for PD for 8 years now. The main medication is Sinemet 250/50 (1/2 pill 5 times daily / 3 hours gap between each dose starting 7:00am). Everything was going normally until recently her blood pressure started to get high at the end of each dose period, about 30 minutes before the next dose. This is making her very depressed and sometimes entering in a panic attack. Her physician prescribed Coversyl 5mg (Arginine) / one pill at night, and, Betaloc Zoc 50mg (Metoprolol tartrate) / one pill in the morning, but still the BP is not regulated. Here's a list of other medications mom is taking regularly: -Cipralex 10mg (Escitalopram) : 1 pill in the morning - 1/2 pill at noon. -Sifrol ER 0.375 (pramipexole) : 1 pill at night. Please advise. Thank you & regards
  15. Hello all. My name is James and I am new around here. My father, James Sr., has fairly advanced PD. He has freezing episodes throughout the day and occasional dyskinesia, albeit only slightly at this point. I am looking for advice on finding a registered dietitian with knowledge and experience in the relationship between protein and Sinemet. I’ve just ordered two of your books, Kathrynne, (Cook Well, Stay Well & Eat Well, Stay Well), and I know they will be a great help. However, my father struggles with reading more than a few pages at a time and processing the information (I know the audio CD with one of them will help). Having a dietitian sit down with him and building a relationship would be great. I have called a few local dietitians (my father is in Southern NJ, i.e. Medford) and, frankly, I am a little surprised how little all three knew about the interaction between protein and Sinemet despite listing expertise in gerontology. They all could help with a low protein diet, of course, but it would be great to have a dietitian who had knowledge specifically, in protein, levodopa and absorption. I am wondering the typical route taken in order to build a relationship with a dietitian, also, and I don't know if it is appropriate to ask this here, but I am looking for recommendations for Registered Dieticians in the Southern New Jersey area that have experience with the interaction between protein and levodopa. I know the books will be a great start, but building a personal relationship with someone would be great. Again, if this is not a great place to ask this question, I apologize and just let me know. Thanks! Best, James Johnson Jr.
  16. There are many reasons to think carefully before allowing your neurologist or MDS to talk you into starting PD drugs. Current PD meds only treat the symptoms, not the disease. Are the benefits worth the side effects? Are the PD meds addictive - do you constantly need more and more to achieve the same result? These issues have often been debated on the forum. However, there is another important thing to consider when faced with the decision to begin taking PD meds. When you take that first does of Sinemet or an agonist, you are eliminating yourself from being able to participate in many of the exciting new clinical trials. That is exactly what happened to me in the Isradipine trial. That 4 months that I took PD meds (Mirapex) eliminated me from the Isradipine trial, even though I stopped Mirapex many months ago. The same will be true of the Inosine trial next year. Take PD meds and you're out! I wish I had never taken that first PD med. The irony is that it was only moderately effective and the side effects were worse than the PD, which is why I stopped.
  17. Amantadine and Dyskenisa

    Thought I would poll the hive-mind on what I've experienced by adding Amantadine to my RX cocktail, to find out if it is normal or am I unique in my experience of this drug. Because what I expected to happen didn't. Good news is I've experienced no noticeable side effects from taking it like many people report. I've been on it for about 3 weeks so far. This is being added to Sinemet 25/100mg 3x/day, and Azilect 1mg 1x/day. I've understood it helped with dyskenisa. My impression is that by taking it, it would help clear up those symptoms. The neuro prescribed it to help "smooth out" the symptoms. He did indicate I might want to lower my Sinemet intake down, suggesting to start with half a pill in the afternoons, but told me to experiment based on what my body is telling me. I decided to just take it (100 mg 2x/day) without changing anything else to see what would happen. It smoothed out the symptoms okay, including spreading my peak dyskenisa of about 30 minutes to 1 hour per Sinemet pill does every 6 hours to last closer to 5 hours. Well, that certainly wasn't progress. I'll take the 2-4 hours of dyskenisa a day over most of the day. But then it dawned on me. Perhaps I need to reduce the amount of Sinemet I'm taking to avoid dyskenisa. That the Amantadine also enhances the dose of Sinemet to last longer as well. So I took a half-pill at my next appointed time of Sinemet instead of the full pill. I still ended up with some dyskenisa, but it was noticeably less intense and didn't last as long. I then tried taking the Sinemet some time after the Amantadine instead of together as I had been doing, as I noticed very little dyskenisa in the afternoon Sinemet dose compared to when I took them together. That pretty much got rid of the initial minor dyskenisa. I discovered if I waited at least 1 hour after taking the Amantadine before taking my half-Sinemet pill, preferably 2, I experienced no to barely noticeable dyskenisa. It is down now to the point I'm taking only 1 to 1.5 pills of Sinemet a day. That leaves me with a very minor tremor and left-arm dystonia. When I feel those getting worse, I take another half-pill of Sinemet. I don't feel totally back to "normal" as if I didn't have PD, but it is quite a bit more manageable. And the big plus for me is my left fingers are responsive enough I can type more each day without my fingers wanting to contract. I'm thinking at least for the time being, I've found a good combo, if I can stay balanced on the edge without falling into much dyskenisa. But would it be then true that Amantadine works to lessen dyskenisa not by counteracting the effects of high dopamine on the central nervous system, but by enhancing the dopamine you are getting so you can cut back on the Sinemet to the point your intake is below dyskensia-producing amounts? That appears to be my experience, but I thought it was the other way around.
  18. Dr Okun, Now on Sinemet 100/25 ,1 1/2 tab 4t/d (6:00, 11:00, 16:00, 23:00 hrs). About to start Selegiline 5mg 2t/d. I read that it is very likely that I will need to reduce Sinemet a bit as Selegiline increases Sinemet efficacy. How much of a reduction should I expect for and on which dose. I know the snowflake metaphor that we are all different; I am just looking for a range. I.E. expect to reduce 3rd and 4th Sinemet doses from 1 1/2 to 1. Or may be even in increment of 1/4 tab? Also, how soon after starting Selegiline can one expect to see an effect on the symptoms/side effects? days weeks? Thank you Norm
  19. Patient assistance program

    Good afternoon... Being I have no extended health care for prescriptions I starting searching for help from the company ( Merck)who produces Sinemet. To my surprise I found out that Merck does in fact have a wonderful program for the people taking Sinemet. It's called "My Choice" The card allows you to have the brand name Sinemet drug for the same price as the generic. I took my RX help card in when I filled my prescription. Instead of paying $69.00 for my pills I paid $29.00 and walked out with Sinemet Brand Name... This is wonderful for those who want to be on the brand name but the cost is easier on the pockets to go generic... I love a deal....I love passing it over to other even more..... I'm Canadian so I'm not sure how the USA program runs...but it's an American company with a Canaidian subsidiary office in Montreal. It should have something of the same in the USA. Hope it can help other!!! Laura
  20. Is there a limit on Sinemet per day

    Hello doctors, I have a post going with Kathrynne Holden, but I have a doctor question now. I was diagnosed with PD in 2006. I am 62 years old. I am at the point that I take 3 25/100 100 tablets of Sinemet every 2 hours. Is there a maximum total mg one can take per day before it becomes unhealthy? Thank you
  21. Does taking Sinemet slows down Parkinson’s progression or accelerates the disease progression or it has no effect at all on disease progression?
  22. Dear Members of the Forum, I am living with and caring for my 74-year-old mother, who has PD for the last 15 years. We are in a process of adjusting her medications (again) and although I was introduced to the concept of on-off preiods I (and our neurologist) have hard time identifying whether my mom has an off-period or she feels bad because there might be too much of medication or it is not absorbed as it should. I made a movie of when my mom was feeling bad, which happened at the same time every day (45 minutes after her third dose of Sinemet) and showed it to our doctor. He said that it looks like too much medication. We tried reducing the dose but it didn't improve anything. Now I start thinking that maybe it's the opposite? That is, that this is her "off period". I would greatly appreciate if you could share your experience of what it means for you to be in an "off period". Do you have dyskinesia? Accute pains? Spasms? (where?) Agitation? Short breath? Any specific information would help me and my mom to at least identify her problem. Many many thanks in advance.
  23. Impax Pharmaceuticals Announce FDA Approval of RYTARY™ (Carbidopa and Levodopa) Extended-Release Capsules for the Treatment of Parkinson's disease PR Newswire January 08, 2015: 08:01 AM ET HAYWARD, Calif., Jan. 8, 2015 /PRNewswire/ -- Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced that the U.S. Food and Drug Administration (FDA) approved RYTARY, an extended-release oral capsule formulation of carbidopa-levodopa, for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and / or manganese intoxication. RYTARY is not for use in patients using nonselective monoamine oxidase inhibitors (MAO) inhibitors. Logo - http://photos.prnewswire.com/prnh/20140402/PH96035LOGO "The FDA approval of RYTARY (pronounced rye-TAR-ee) is an important new development for the treatment of Parkinson's disease and provides an extended-release carbidopa-levodopa product that treats Parkinson's disease," said Fred Wilkinson, president and CEO, Impax Laboratories. "RYTARY is designed to address one of the most significant unmet needs for patients living with Parkinson's disease, which is to reduce the amount of time during the day when their symptoms are not adequately controlled." "There are approximately one million Americans living with this chronic disease and we are pleased to offer this new therapy as a treatment option for those patients," added Wilkinson. "Today's approval of RYTARY is also a significant milestone for Impax because it is our first branded drug internally developed and approved for commercialization." RYTARY contains immediate release and extended-release beads, with a specific amount of carbidopa and levodopa in a 1:4 ratio, and provides both initial and extended levodopa plasma concentrations after a single dose. RYTARY may be swallowed whole or, for patients who have trouble swallowing, the capsule may be opened and the beads sprinkled on applesauce and consumed immediately. Impax expects the four strengths of RYTARY, 23.75mg/95mg, 36.25mg/145mg, 48.75mg/195mg, and 61.25mg/245mg (carbidopa/levodopa) to be available for commercial distribution in February 2015. The RYTARY clinical program studied patients with early (levodopa-naive) to advanced Parkinson's disease in the U.S. and in Europe. In APEX-PD (Study 1), a trial that enrolled and randomized 381 levodopa-naive patients, the study met its primary efficacy endpoint of mean change from baseline in the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily living) score and UPDRS Part III (motor skills) score for RYTARY versus placebo at Week 30 (or early termination). In ADVANCE-PD (Study 2), a trial of 393 randomized patients with advanced Parkinson's disease having "off" time, the results showed treatment with RYTARY reduced the percentage of "off" time (36.9% to 23.8%) from baseline versus immediate-release carbidopa-levodopa (36.0% to 29.8%) during waking hours to end of study. RYTARY also increased "on" time without troublesome dyskinesia during waking hours versus baseline to end of study by 1.8 hours. Less "off" time was primary related to more "on" time without troublesome dyskinesia. The most common adverse reactions with RYTARY in the APEX-PD trial (in at least 5% of patients and more frequently than in placebo) were nausea, dizziness, headache, insomnia, abnormal dreams, dry mouth, dyskinesia, anxiety, constipation, vomiting, and orthostatic hypotension. The most common adverse reactions with RYTARY in the ADVANCE-PD trial (in at least 5% of patients and more frequently than an oral immediate-release carbidopa-levodopa) were nausea and headache. About Parkinson's disease Parkinson's disease is a chronic neurodegenerative movement disorder affecting approximately one million people in the U.S., with 50,000-60,000 new cases diagnosed each year in the U.S. alone. There is currently no known cure for Parkinson's. About RYTARY IMPORTANT SAFETY INFORMATION RYTARY is contraindicated in patients who are currently taking or have recently (within 2 weeks) taken a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine and tranylcypromine). Hypertension can occur if these drugs are used concurrently. Patients treated with levodopa (a component of RYTARY) have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents. Although many of these patients reported somnolence while on levodopa, some perceived that they had no warning signs (sleep attack), such as excessive drowsiness, and believed that they were alert immediately prior to the event. Some of these events have been reported more than 1 year after initiation of treatment. Before initiating treatment with RYTARY, advise patients of the potential to develop drowsiness and specifically ask about factors that may increase the risk for somnolence with RYTARY such as concomitant sedating medications or the presence of a sleep disorder. Prescribers should consider discontinuing RYTARY in patients who report significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., conversations, eating, etc.). If a decision is made to continue RYTARY, patients should be advised not to drive and to avoid other potentially dangerous activities that might result in harm if the patients become somnolent. A symptom complex that resembles neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in dopaminergic therapy. Avoid sudden discontinuation or rapid dose reduction in patients taking RYTARY. If the decision is made to discontinue RYTARY, the dose should be tapered to reduce the risk of hyperpyrexia and confusion. Cardiovascular ischemic events have occurred in patients taking RYTARY. In patients with a history of myocardial infarction who have residual atrial, nodal, or ventricular arrhythmias, cardiac function should be monitored in an intensive cardiac care facility during the period of initial dosage adjustment. There is an increased risk for hallucinations and psychosis in patients taking RYTARY. Hallucinations present shortly after the initiation of therapy and may be responsive to dose reduction in levodopa. Hallucinations may be accompanied by confusion and sleep disorder (insomnia) and excessive dreaming. Abnormal thinking and behavior may present with one or more symptoms, including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behavior, disorientation, aggressive behavior, agitation, and delirium. Because of the risk of exacerbating psychosis, patients with a major psychotic disorder should not be treated with RYTARY. In addition, medications that antagonize the effects of dopamine used to treat psychosis may exacerbate the symptoms of Parkinson's disease and may decrease the effectiveness of RYTARY. Case reports suggest that patients can experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge eating, and/or other intense urges, and the inability to control these urges while taking one or more of the medications, including RYTARY, that increase central dopaminergic tone and that are generally used for the treatment of Parkinson's disease. In some cases, although not all, these urges were reported to have stopped when the dose was reduced or the medication was discontinued. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to specifically ask patients or their caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending, or other urges while being treated with RYTARY. Consider a dose reduction or stopping the medication if a patient develops such urges while taking RYTARY. RYTARY can cause dyskinesias that may require a dosage reduction of RYTARY or other medications used for the treatment of Parkinson's disease. Treatment with RYTARY may increase the possibility of upper gastrointestinal hemorrhage in patients with a history of peptic ulcer and may cause increased intraocular pressure in patients with glaucoma. RYTARY should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when RYTARY is administered to a nursing woman. Overdosage The acute symptoms of levodopa/dopa decarboxylase inhibitor overdosage can be expected to arise from dopaminergic overstimulation (cardiovascular and CNS disturbances). Drug Interactions: Monitor patients taking selective MAO-B inhibitors and carbidopa-levodopa. The combination may be associated with orthostatic hypotension. RYTARY should be co-administered cautiously with: dopamine D2 antagonists (metoclopramide), isoniazid, and iron salts. RYTARY should not be chewed, divided, or crushed. About Impax Pharmaceuticals Impax Pharmaceuticals is the branded products division of Impax Laboratories, Inc. Impax Pharmaceuticals is focused on targeting significant unmet needs, with a primary focus on developing treatments for neurological disorders. For more information, please visit its web site at www.impaxpharma.com. About Impax Laboratories, Inc. Impax Laboratories, Inc. (Impax) is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of central nervous system disorder branded products. Impax markets its generic products through its Global Pharmaceuticals division and markets its branded through the Impax Pharmaceuticals division. Additionally, where strategically appropriate, Impax develops marketing partnerships to fully leverage its technology platform and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams, and ointments. For more information, please visit the Company's web site at: www.impaxlabs.com. "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995: To the extent any statements made in this news release contain information that is not historical; these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the Company's future results, performance, or achievements to differ significantly from the results, performance, or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to: fluctuations in revenues and operating income; the Company's ability to promptly correct the issues raised in the warning letter and Form 483 observations received from the FDA; the Company's ability to successfully develop and commercialize pharmaceutical products in a timely manner; reductions or loss of business with any significant customer; the impact of consolidation of the Company's customer base; the impact of competition; the substantial portion of our total revenues derived from sales of a limited number of products; the Company's ability to sustain profitability and positive cash flows; any delays or unanticipated expenses in connection with the operation of the Company's manufacturing facilities; the effect of foreign economic, political, legal, and other risks on the Company's operations abroad; the uncertainty of patent litigation and other legal proceedings; the increased government scrutiny on the Company's agreements with brand pharmaceutical companies; product development risks and the difficulty of predicting FDA filings and approvals; consumer acceptance and demand for new pharmaceutical products; the impact of market perceptions of the Company and the safety and quality of the Company's products; the Company's determinations to discontinue the manufacture and distribution of certain products; the Company's ability to achieve returns on its investments in research and development activities; the Company's inexperience in conducting clinical trials and submitting new drug applications; the Company's ability to successfully conduct clinical trials; the Company's reliance on third parties to conduct clinical trials and testing; the Company's lack of a license partner for commercialization of IPX066 outside of the United States; impact of illegal distribution and sale by third parties of counterfeits or stolen products; the availability of raw materials and impact of interruptions in the Company's supply chain; the Company's policies regarding returns, allowances and chargebacks; the use of controlled substances in the Company's products; the effect of current economic conditions on our industry, business, results of operations and financial condition; disruptions or failures in the Company's information technology systems and network infrastructure; the Company's reliance on alliance and collaboration agreements; the Company's reliance on licenses to proprietary technologies; the Company's dependence on certain employees; the Company's ability to comply with legal and regulatory requirements governing the healthcare industry; the regulatory environment; the Company's ability to protect its intellectual property; exposure to product liability claims; risks relating to goodwill and intangibles; changes in tax regulations; the Company's ability to manage growth, including through potential acquisitions; the Company's ability to meet expectations regarding the timing and completion of the proposed transaction with Tower Holdings Inc. and Lineage Therapeutics Inc., the Company's ability to consummate such proposed transaction; the conditions to the completion of such proposed transaction (including the receipt of the regulatory approvals required for the transaction not being obtained on the terms expected or on the anticipated schedule), the integration of the acquired business by the Company being more difficult, time-consuming or costly than expected, operating costs, customer loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees, customers, clients or suppliers) being greater than expected following the proposed transaction, the retention of certain key employees of the acquired business being difficult, the Company's and the acquired business's expected or targeted future financial and operating performance and results, the combined company's capacity to bring new products to market, and the possibility that the Company may be unable to achieve expected synergies and operating efficiencies in connection with the proposed transaction within the expected time-frames or at all and to successfully integrate the acquired business, the restrictions imposed by the Company's credit facility; uncertainties involved in the preparation of the Company's financial statements; the Company's ability to maintain an effective system of internal control over financial reporting; the effect of terrorist attacks on the Company's business; the location of the Company's manufacturing and research and development facilities near earthquake fault lines; expansion of social media platforms and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise. Company Contact: Mark Donohue Investor Relations and Corporate Communications (215) 558-4526 www.impaxlabs.com To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/impax-pharmaceuticals-announce-fda-approval-of-rytary-carbidopa-and-levodopa-extended-release-capsules-for-the-treatment-of-parkinsons-disease-300017730.html SOURCE Impax Laboratories, Inc.
  24. Sinemet Challenge

    I've finished my first week of the Sinemet challenge. The good news is that there has been some improvements with the rigidity and other things. That is also the not so awesome news. My doctor believes I have YOPD and wanted to back that up with the dopamine test. It's been an interesting few years that have led up to this point but I'm glad to have finally arrived at an answer. I'm still not sure what to think of it all but I'm sure I'll do just fine. How far in the dopamine challenge did you get before noticing some improvements?
  25. What sort of non-motor symptoms does Sinemet help with? I don't feel as cranky since I'm not hurting as much. Beyond that though, what have been your experiences with non-motor symptoms and Sinemet?