Q. According to the TIME article "The Power of the Mood" Jan 20, 2003, FDA approved MAOIs in transdermal patch form. Do you know if this is true and when it will be available?

A. Unfortunately, Somerset Pharmaceuticals informs me that the Time magazine article was in error. (I have suggested to the company that they put out an appropriate advisory to the general public on this, since many people will undoubtedly be disappointed).

According to a spokesperson for the company, the FDA has NOT yet approved the transdermal delivery form of selegiline (formerly l-deprenyl) for use as an antidepressant. I am not sure what the hold up is, and the spokesperson did not discuss this with me; however, she did say that the company does not know when approval will be granted.

But, for your information, and as per the NARSAD website, "?the only antidepressant under development for transdermal delivery is selegiline (formerly l-deprenyl), an atypical monoamine oxidase inhibitor (MAOI) originally developed as an adjunctive antiparkinsonian drug. Unlike oral selegiline, which behaves like a conventional MAOI at doses required for antidepressant efficacy, the transdermal patch does not increase tyramine sensitivity, so that dietary restrictions are not required. This patch may be especially beneficial for individuals who need to take an MAOI, have atypical depression, or exhibit psychomotor retardation (slowed motor movement).

The first clinical trial showed that transdermal selegiline was effective for depression after one week of treatment. This delivery system was well-tolerated with only 36% of subjects having local skin irritation compared to 17% with placebo. Treatment compliance was unusually high, with 89% of subjects on active drug completing the trial and nearly 100% of patches used.

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May 2003

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