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Re: History of emsam as I know it yldouglas

Posted by chemist on May 11, 2005, at 21:31:06

In reply to History of emsam as I know it, posted by yldouglas on May 11, 2005, at 19:09:02

hello there, chemist here...this is an interesting post and topic...i have a comment or two and some questions, delineated by asterisks....all the best, chemist

> I've been following the development of the emsam patch for several years as I am at the end of the line for antidepressants (Wellbutrin for 5 years now)
> Two pharm co's (Watson and Mylan) formed a joint venture, Somerset, which handles L-deprenyl for Parkinson's disease patients. L-deprenyl is selegiline which is the active ingredient in the EmSam Patch. L-deprenyl is a MAO-B inhibitor under doses of 15-20 mg. Once you go over that dosage, it becomes a MAO-A inhibitor, which has deadly side effects (called the tyramine reaction), which is a reaction to certain foods and medications such as aged cheese, wine, and many others. But that reaction all happens in the "gut" or digestive system.
> L-deprenyl works on the dopamine receptors (Wellbutrin is the only anti-depressant that does anything significant with dopamine, which is why they slightly changed the formulation, made a new pill, called it Zyban and marketed it for people trying to quit smoking as nicotine stimulates the dopamine system. This is why I can smoke whenever I want and stop cold turkey and basically don't notice a thing. sorry for the tangent) Anyway, someone, somewhere discovered that at higher doses, L-deprenyl works great as an anti-depressant.
> One of the two companies has developed transdermal patch systems that can handle larger molecules than those already on the market. They got together with the L-deprenyl people and figured out that if you could make L-deprenyl into a transdermal patch where the medication would go directly into the blood stream, bypassing the digestive system, you could deliver higher doses without the danger of the tyramine reaction.
> They started testing and had amazing results (if we can believe them and I actually do) with no tyramine reactions occurring. They received approval from the FDA in February 2004 but wanted Somerset to include a warning on the tyramine effect. The company strongly feels they have the evidence that this is not necessary and know if they have to put that warning out there it will adversely affect sales. So they've been struggling with the FDA to leave that warning off the labeling.
**** actually, the letter was ``approvable,'' and not ``approval:'' the letter to which you refer was following a ``non-approvable'' letter delivered to Somerset and Watson 1Q2002. the MAO-A/B switch that you mention is a mystery: the drug is an MAO-B inhibitor as low doses, and a dopamine uptake inhibitor at high doses. the ``someone, somewhere'' discovery that ``high doses'' of the drug working as an antidepressant are over 30 years old, as is the drug (1962, actually). ****

> The good news is Somerset has reached an agreement with Bristol Myers Squib to be the distributor for the patch. The hope is BMS will be able to use its clout to resolve the labeling issue with the FDA.
> This is making me crazier than I already am. I have wanted to try this patch for four years since I first read about it and really thought it would be available the first half of 2004. I can't believe another year has passed and it is still being kept captive by the FDA. I'm hoping BMS can finally make it happen. I have talked directly to people in the investment departments of both companies (no one else would respond), which is how I know all this info. I will try to find some time to do some more research and try to get an update. If I succeed I will come back and post the latest. I hope this helps any and all of you looking for relief.
> Aloha,
> yldouglas.
**** could you be so kind as to pass along the names and contact information for the people to whom you have had contact at both BMS and Somerset? you can enable babblemail if you wish, although in the interest of furthering the effort, perhaps a public posting is better - your choice, of course...but i am very eager to talk to them and, incidentally, to you as well...all the best, chemist ****




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