March 3, 2006

MAOI patch approved

Filed under: FDA,Therapeutic pipeline

The FDA just approved the first transdermal one-a-day anti-depressant: Emsam, an MAO inhibitor. In theory, this patch allows patients to continue eating the foods that they enjoy — at least at the lowest dose, which they wouldn't be able to do with a tablet. Higher strengths allow no such luxury.

With the amazing assortment of drug interactions that MAOIs have, I question whether this is really beneficial for anyone. I can honestly say that I've seen one prescription for an MAOI in the last three years. With the advent of safer anti-depressants — the SSRIs — and the rightfully-earned stigma against MAO inhibitors, I wonder if Emsam really has a market. Sure there will be some sales, but given that it costs ~$500 million to bring a new drug to market, will it recoup its own R&D costs before its patent expires?

[tags]selegiline, MAO inhibitors, Emsam, SSRIs, anti-depressants[/tags]

View Comments | 10:51 am |
  • RJS
    Hello Tom, thanks for your reply.

    I think you misunderstand; the medical profession recognizes that anti-depressants aren't effective in everyone. Most drugs aren't, but my skepticism isn't over the efficacy of the patch, but rather the safety of MAOIs and the viability of this drug financially. Obviously my experience is anecdotal, but we fill maybe one prescription for an MAOI per year. I'm sure the numbers are higher in cities, but this is a tiny niche for a drug.

    MAOIs are a tiny part of the anti-depressant market compared to SSRIs, and the medical community's reluctance to use them is due to the numerous side effects and drug interactions associated with them. Because Emsam is transdermal, many of the first-pass effects are eliminated, which gets rid of many of the dietary restrictions associated with MAOIs (for example), but the class of drugs as a whole still has a (rightfully-deserved) stigma attached to them which will likely limit the real-world impact of this drug, for better or worse.
  • Tom Fontana
    Considering that SSRI's have been shown to be effective only 40% of the time at their best, I would say that this patch will initially have a large market.

    As someone that has been treated with SSRI's for 17 years, only to find them currently ineffective, I will jump at the chance to try this patch.

    It's time for the medical profession to stop diefying SSRI's. There is a great need for new or improved antidepressant medications.

    Tom Fontana
  • marie
    yes there are…I am one of them.
    phenelezine has been the only antidepressant that has offered me any relief. However, after some time of using it, the side effects begin to outweigh its benefits. This is partly because I have had some liver disease in the past and it is therefore difficult for me to metabolize many drugs.
    I have been hoping for this for a very long time.
    Yes, the diet restrictions can be a pain. But even more troublesome is the drug having to go through my whole system.
    A patch, of course, would bypass that.
    Unfortunately, I am in Canada and have not been able to find any info here.
    I don’t think it is approved here.
    any feedback would be welcomed
    Marie
  • Judy Aylvia
    I have been using an Maoi inhibiter for about 8 years. I have tried all the other new and old drugs and they either did not work or I could not tolerate the side effects. I am anxios to try the patch so I can eat like a normal person. I don’t go to restauranst often because there is so little I can eat.

    I am sure there a feww people like me that MAOIs are a lifesend - literly.
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