First Skin Patch to Treat Depression
Key points
- The first transdermal patch to treat depression has been approved by the U.S.
- The FDA approval was based on results of two double-blind, placebo-controlled studies of Emsam.
- The once-a-day patch works by delivering selegiline, a monoamine oxidase inhibitor or MAOI, through the skin and into the bloodstream.
- The final FDA approval comes two years after the agency first said the patch was "approvable.
The first transdermal patch to treat depression has been approved by the U.S. Food and Drug Administration.
The FDA approval was based on results of two double-blind, placebo-controlled studies of Emsam. One study found that six weeks of treatment with Emsam was more effective than a non-medicinal placebo in relieving symptoms of major depression disorder in adults, United Press International reported.
The once-a-day patch works by delivering selegiline, a monoamine oxidase inhibitor or MAOI, through the skin and into the bloodstream. Emsam is designed to interact with three brain neurotransmitters that are believed to play a role in depression. The patch is not approved to treat depression in patients 17 and younger.
The final FDA approval comes two years after the agency first said the patch was "approvable." However, concerns about potential interactions with food and beverages high in tyramine - such as salami, aged cheese, beer, and wine - contributed to the delay in Emsam gaining final approval, MarketWatch reported.
It's believed that Emsam's active ingredient - selegiline - could interact with tyramine and cause a sudden, rapid increase in blood pressure. The FDA said patients who use the higher dose patches - 9 and 12 milligrams per 24 hours - must be advised to avoid foods and beverages high in tyramine. Patients who use the lowest dose - 6 milligrams - do not require any dietary restrictions, MarketWatch reported.
HealthDay News
Written and revised by
Gerald Hurowitz, M.D.
Our doctors write and review articles for accuracy and keep them up to date.
health.am provides general information, not medical advice. Always consult a qualified health professional about your own health.
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