FDA APPROVES FIRST TRANSDERMAL PATCH FOR DEPRESSION
The FDA has approved Somerset Pharmaceuticals' experimental depression treatment Emsam, the first transdermal patch for the treatment of major depressive disorder in adults.
Somerset is a joint venture between Mylan Laboratories and Watson Pharmaceuticals. Bristol-Myers Squibb (BMS) has exclusive U.S. and Canadian distribution rights for Emsam (selegiline). Clinical trials of the drug, a monoamine oxidase inhibitor (MAOI), have shown a "significant improvement" in depressive symptoms, BMS said.
At its lowest strength, Emsam can be used without the dietary restrictions needed for all oral MAOIs approved for treating major depression, the FDA said. When combined with certain foods, MAOIs can cause a sudden, steep increase in blood pressure, or "hypertensive crisis," which can lead to a stroke and death, the agency said.
Oral MAOI antidepressants pass through the digestive tract and can inhibit the breakdown of tyramine, a substance found in certain foods and beverages including aged cheese and tap beer, BMS said. If a large amount of tyramine is absorbed systemically, it can lead to a hypertensive crisis, the company noted.