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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 15 of 15. This is the beginning of the thread.
Posted by harry1 on April 11, 2005, at 19:16:41
Any new news on emsam??
Posted by jclint on April 12, 2005, at 10:34:24
In reply to emsam, posted by harry1 on April 11, 2005, at 19:16:41
Doesn't look like it. I wish they'd hurry up.
Posted by paulbwell on April 13, 2005, at 20:26:05
In reply to Re: emsam, posted by jclint on April 12, 2005, at 10:34:24
Posted by mworkman on April 13, 2005, at 22:49:59
In reply to Re: emsam??????what is it (nm), posted by paulbwell on April 13, 2005, at 20:26:05
They are taking thier sweet time getting it out. Probably waiting for another ad to go off patent. It has been over a year since it was "approvable".
Posted by KaraS on April 14, 2005, at 2:09:39
In reply to Re: emsam??????what is it (nm) » paulbwell, posted by paulbwell on April 14, 2005, at 0:07:38
Selegiline patch
Posted by Paulbwell on April 14, 2005, at 2:46:08
In reply to Re: emsam??????what is it » paulbwell, posted by KaraS on April 14, 2005, at 2:09:39
>
> Selegiline patchIsn't Seligiline a Nootropin (Nutraceutical) -nutrient-drug
Posted by KaraS on April 15, 2005, at 0:14:52
In reply to Re: emsam??????what is it, posted by Paulbwell on April 14, 2005, at 2:46:08
> >
> > Selegiline patch
>
> Isn't Seligiline a Nootropin (Nutraceutical) -nutrient-drugI've seen it called a nootropic drug but it's definitely not a nutrient drug. It's the same medication that is used to treat Parkinson's disease. In dosages above 10 mg. it inhibits MAO-A and MAO-B and therefore requires the MAOI diet. The Ensam patch, that so many people are waiting for, will obviate the need for the MAOI diet. Many people have found selegiline to be a powerful antidepressant.
Kara
Posted by Paulbwell on April 15, 2005, at 17:45:57
In reply to Re: emsam??????what is it » Paulbwell, posted by KaraS on April 15, 2005, at 0:14:52
> > >
> > > Selegiline patch
> >
> > Isn't Seligiline a Nootropin (Nutraceutical) -nutrient-drug
>
> I've seen it called a nootropic drug but it's definitely not a nutrient drug. It's the same medication that is used to treat Parkinson's disease. In dosages above 10 mg. it inhibits MAO-A and MAO-B and therefore requires the MAOI diet. The Ensam patch, that so many people are waiting for, will obviate the need for the MAOI diet. Many people have found selegiline to be a powerful antidepressant.
>
> Kara
>
>
> Being part Nootropic can you purchase it, sans script?Cheers
Posted by KaraS on April 15, 2005, at 19:52:17
In reply to Thanks Kara » KaraS, posted by Paulbwell on April 15, 2005, at 17:45:57
> > > >
> > > > Selegiline patch
> > >
> > > Isn't Seligiline a Nootropin (Nutraceutical) -nutrient-drug
> >
> > I've seen it called a nootropic drug but it's definitely not a nutrient drug. It's the same medication that is used to treat Parkinson's disease. In dosages above 10 mg. it inhibits MAO-A and MAO-B and therefore requires the MAOI diet. The Ensam patch, that so many people are waiting for, will obviate the need for the MAOI diet. Many people have found selegiline to be a powerful antidepressant.
> >
> > Kara
> >
> >
> > Being part Nootropic can you purchase it, sans script?
>
> Cheers
>
In most places, including the U.S., it's a prescription medication only.K
Posted by mrchuffy on April 20, 2005, at 20:31:46
In reply to Re: emsam??????what is it » Paulbwell, posted by KaraS on April 15, 2005, at 0:14:52
Anyone know if EMSAM will be available in The UK? Also whats the difference in efficacy between Selegiline and Moclobemide? Are they not both MAO- B inhibitors?
Posted by KaraS on April 24, 2005, at 1:31:36
In reply to Re: emsam??????what is it, posted by mrchuffy on April 20, 2005, at 20:31:46
> Anyone know if EMSAM will be available in The UK? Also whats the difference in efficacy between Selegiline and Moclobemide? Are they not both MAO- B inhibitors?
I don't know if the selegiline patch will be available in the UK.Selegiline is only selective for MAO-B at doses of 10 mg. or less. Over 10 mg. it inhibits MAO-A as well.
Posted by mrchuffy on May 2, 2005, at 19:21:11
In reply to Re: emsam??????what is it » mrchuffy, posted by KaraS on April 24, 2005, at 1:31:36
Thanks for the info. I've got me a box of Mocloblemide and im gonna give it a go. Hopefully it'll help with the panic/depression and wont make me A. Incontinent, B. Impotent or C. manic, like those damn SSRIs. ;-)
Posted by yldouglas on May 11, 2005, at 20:06:51
In reply to emsam, posted by harry1 on April 11, 2005, at 19:16:41
Quote:
In December 2004, pharmaceutical firms Bristol-Myers Squibb and Somerset Pharmaceuticals announced they had entered into an agreement to distribute and commercialize EMSAM, the first transdermal treatment for major depression. If the FDA permits, the patch will be marketed in 2005 for both acute and long-term depressive disorder. The FDA's EMSAM "approvable" letter of February 2004 indicated that the efficacy data supported granting a product license. Such approval is by no means a foregone conclusion. It is claimed that EMSAM's pharmacokinetic and pharmacodynamic properties promote the inhibition of MAO-A and MAO-B in the CNS while avoiding significant inhibition of intestinal and liver MAO-A enzyme; but labeling discussions will inevitably focus on the prudence of tyramine dietary restrictions.
Posted by yldouglas on May 11, 2005, at 20:12:27
In reply to Re: emsam, posted by yldouglas on May 11, 2005, at 20:06:51
It seems my earlier posting disappeared, probably because I changed the subject line. "History of EmSam as I know it."
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.
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.
Posted by Psyc 1 on May 14, 2005, at 23:08:38
In reply to Re: emsam, posted by yldouglas on May 11, 2005, at 20:12:27
I too have been anxiously awaiting the approval of Emsam. The game the FDA is playing with this is maddening. Very frustrating for those of us who can't tolerate SSRIs.
This is the end of the thread.
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