Somerset's low-dose Emsam (selegiline) patch for major depression should be marketed without dietary restrictions, FDA's Psychopharmacologic Drugs Advisory Committee recommended Oct 26.

"I was convinced that there's no harm signal in either the clinical trials data that were represented or the more extensive database for the use of Eldepryl ," Committee Chair Wayne Goodman (University of Florida) said.

Furthermore, Goodman said, "benefit is clearly an issue here….We do have other [monoamine oxidase inhibitors] on the market but it's clear to me that this is going to produce far less risk than our existing medications of having a hypertensive reaction."

The committee voted 7-4 that the 20 mg patch could be marketed without restrictions on foods with a high tyramine content, such as cheese and red wine.

FDA initially proposed that all three strengths of Emsam require dietary restrictions; Somerset, a Mylan/Watson joint venture, has agreed to the restrictions for its 30 mg and 40 mg strengths.

High levels of tyramine, which is metabolized by MAO, lead to elevated blood pressure and possibly hypertensive crisis (¹ Also see "Somerset's Low-Dose Emsam Patch Needs Dietary Restrictions, FDA Reviewer Says" - Pink Sheet, 25 October, 2005.).

Somerset presented the committee with safety data from clinical trails covering 2,503 patients, a tyramine challenge program with 214 subjects across 14 studies and post-marketing data from currently marketed oral selegiline (Somerset's Eldepryl and generics).

"I thought that the analysis, not only of hypertensive crisis, but of all the symptoms that can be associated with hypertension itself were looked at a number of different ways, and I don't think that any of us saw a signal there," committee consultant Carol Tamminga (University of Texas) said.

Committee members who voted for dietary restrictions for all dosage strengths cited small sample sizes for the tyramine challenge program studies and low patient compliance with the varied dietary requirements.

The committee also voted 6-4 that it would be acceptable to market the 20 mg patch without dietary restrictions while simultaneously requiring the restrictions for the 30 mg and 40 mg patch strengths.

- Brian Marson

Somerset Low-Dose Emsam Does Not Need Dietary Restrictions, Committee Says

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