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Similar concerns about transdermal delivery have been expressed about EMSAM.
The Emsam patch will be made available in three sizes that deliver 6, 9, or 12 mg of selegiline per 24 hours.
* Comment: In two studies of 400 outpatients with major depressive disorder, those treated with the Emsam patch for 68 weeks had significantly more improvement in a depression rating scale than did those on placebo.
However, most of those polled at the meeting indicated they would be unlikely to use transdermal selegiline (Emsam), which is manufactured by Somerset Pharmaceuticals Inc.
The product, which is being marketed under the trade name Emsam, is the first transdermal medication that the FDA has approved for treating major depression.
In three studies lasting 6, 8, or 52 weeks, treatment with 20 mg, 30 mg, and 40 mg of Emsam was significantly more effective than placebo in treating depression, based on different primary end points.