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FDA OKs skin patch to treat depression
Wednesday, March 01, 2006

The Food & Drug Administration yesterday approved the first skin patch to treat depressed adults, a brand-name medication produced in part by generic manufacturer Mylan Laboratories Inc.

The approval is the latest example of the Canonsburg-based company's expertise in medication patches, said Patrick Fitzgerald, spokesman for Mylan. Last year, the company introduced the first generic version of Johnson & Johnson's painkilling patch Duragesic -- one of four generic patches from the company's Mylan Technologies subsidiary. Besides those from Mylan, there are only two other generic patches on the market, Mr. Fitzgerald said.

Sold under the name Emsam, the anti-depression patch is the first name-brand patch offering from Mylan, although the company isn't acting alone. The patch was developed by Somerset Pharmaceuticals Inc., which is a joint venture between Mylan and Watson Pharmaceuticals Inc., and will be marketed by Bristol-Myers Squibb Co.

The antidepression drug contained in the patch isn't new, but delivering it through a patch reduces the safety risk of eating certain foods while taking a low-dose form of the antidepressant. That's because Emsam is absorbed into the bloodstream over a 24-hour period, thereby minimizing exposure to the digestive tract.

While patients using the patch at a strength of 6 milligrams every 24 hours don't need to restrict their diet, higher-dose versions require that patients avoid food and beverages high in tyramine, a substance found in aged cheese, tap beer and other products. Absorbing a large amount of tyramine systemically can lead to a large, sudden increase in blood pressure.

Mr. Fitzgerald said the company had hopes for patches other than Emsam because "transdermal products have the potential to lower side-effects, bring about a reduction in pill burden and [provide] other potential benefits."

Mylan did not release sales estimates for the new patch, which is for patients with major depressive disorder.

The company's stock was off yesterday by nearly 3 percent, closing at $23; for the calendar year, Mylan is up about 15 percent.

First published on March 1, 2006 at 12:00 am
Christopher Snowbeck can be reached at csnowbeck@post-gazette.com or 412 263-2625.