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Domperidone in the U.S.

domperidone FDA IND

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#1 SuzyLong

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Posted 12 December 2012 - 02:52 PM

Does anyone in the U.S. know of a neurologist or gastroenterologist who has filled out an

Investigational New Drug Application

for domperidone?

Background on my question: As one of those unfortunate patients who is particularly sensitive to levodopa induced nausea, life became much more bearable when I discovered domperidone. Until a couple months ago, my neurologist wrote prescriptions for me for domeperidone, then I would fax the prescription to Canada or Great Britian to one of a couple of licensed online pharmacies that had been checked out by independent third parties. A few weeks later, I would have a shipment of domperidone at my doorstep. Recently this ended when the FDA started cracking down on online pharmacies shipping domperidone to the U.S.. They would like patients who need domperidone to fill out an IND application to aquire the drug, a set of forms so long and painful that my neurologist isn't interested. (I don't blame her.) I'm searching for a neurologist who has already filled out the forms for another patient, whom I could visit as a patient and convince to cut and paste my name into previous documents and resubmit on my behalf. Has anyone been through this process? Does anyone have another source for domperidone in the U.S.?

#2 raphaekg

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Posted 16 December 2012 - 08:25 AM

Hi. I don't know of anyone who had an IND completed for domperidone. It sounds like this would be a hard case to make, because an emergency IND requires a "life threatening condition..." or "major irreversible morbidity" that is severely debilitating. My PD doc had been writing me an rx for domperidone and I would have it filled through a Canadian pharmacy, like you. For about a year and a half, no problem. Domperidone was the only drug that stopped my levodopa-induced nausea. As you know, because the FDA is cracking down on Canadian mail order pharmacies, I was totally panicked. However, I did find one (buylowdrugs.com) that was able to get it through customs, with no problem. My PD doc suggested that, if this pharmacy stops carrying it, my best bet is to make an annual trip to Canada, see a Canadian PD doc there, and stock up for the year.
Please let me know whether you have success with this online pharmacy. Another option suggested by my doc was to try a US-based compounding pharmacy (though the FDA oversight of these pharmacies leaves me more than a little scared!). I hadn't considered the emergency IND route -- I am a research scientist who has some experience in dealing with the FDA. Perhaps, if patients can create a 'model emergency IND' for domperidone for PD patients, docs will be more willing to fill out the paperwork.

#3 kynlyn

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Posted 17 December 2012 - 02:19 AM

I also have been having my prescription for Domperidone filled through a Canadian pharmacy. I told my MDS that they were no longer shipping to the US at my last appt a couple of weeks ago and she said she would look into where else we could get it. I am supposed to go back in for Botox injections this week and hopefully she will have an answer for me. I looked around online though and found that Israel is still selling Domperidone for shipment to the US at Isrameds.com. I have not tried to use this site yet, but it looks promising.

#4 SuzyLong

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Posted 20 December 2012 - 08:56 AM

Thanks for the comments. A couple of FYIs (things I already know) in case anyone else--like kynlyn above-- is hunting for it.
1) Compounding pharmacies in the US won't make domperidone. They can't order the raw ingredients and the FDA cracked down on all of them a few years ago that were making it without a special, very expensive, license. The few exceptions are pharmacies that are tied to clinical trials for the drug, but in most cases, even then the drug comes from Canada.
2) There are sites that still sell domperidone online, but none, so far as I have been able to find, that have any sort of independent verification that they are licensed. Most are in countries that I know very little about their medical systems. (I'm trying to avoid this additional risk, but maybe I can't.)
3) The FDA issued a letter (see http://www.fda.gov/D...s/ucm073070.htm) one of the times that they cracked down on domperidone, telling patients with "gastrointestinal disorders" to have their physicians apply for an IND for domperidone and explaining that the crackdown was intended for lactating mothers using it to enhance breast milk production. I imagine that severe levodopa induced nausea would be reason enough for the FDA to approve an IND, given this policy.





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