FDAnews Drug Daily Bulletin

NO WARNING FOR LOW-DOSE EMSAM, SAYS FDA PANEL

Nov. 4, 2005
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A low-dose version of Somerset Pharmaceuticals' experimental Emsam antidepressant patch can be safely administered without dietary restrictions, according to an FDA advisory panel.

The agency's Psychopharmacologic Drugs Advisory Committee recently voted 7-4 to recommend that the 20-mg version of Emsam (selegiline) does not need a warning label indicating the drug can cause cardiovascular risks when consumed with certain foods. Somerset, a joint venture between Mylan Laboratories and Watson Pharmaceuticals, is seeking approval of Emsam, a monoamine oxidase inhibitor (MAOI), as a treatment for major depressive disorder.

Currently marketed selegiline products, such as Somerset's Eldepryl, carry warnings about hypertensive reactions associated with tyramine, an ingredient contained in several foods, including smoked meats, cheese and red wine.

The panel's recommendation counters an analysis conducted by FDA clinical reviewer Greg Dubitsky, who stated in briefing documents released in advance of the panel meeting that all dosage strengths of Emsam should carry a tyramine warning. Dubitsky concluded that the warning is necessary for the 20-mg version because of the large variability in tyramine sensitivity.

Somerset agrees that a tyramine warning is appropriate for the 30- and 40-mg versions of Emsam, but the company contends that risks associated with the 20-mg patch don't warrant a food reaction warning. Not having to place a warning on the 20-mg patch would be a substantial benefit for Somerset because dietary restrictions are considered a major disincentive to using the orally available MAOIs in the U.S.

(http://www.fda.gov/bbs/topics/NEWS/2005/NEW01248.html)