Bristol-Myers, Somerset get FDA OK for Emsam skin patch for depression

By Elaine Rigoli

Tampa, Fla., Feb. 28 - Bristol-Myers Squibb Co. and Somerset Pharmaceuticals, Inc. announced Tuesday that the Food and Drug Administration approved Emsam (selegiline transdermal system), the first transdermal patch for the treatment of major depressive disorder in adults.

Emsam, a transdermal delivery system manufactured by Mylan Technologies, Inc. for Somerset, is a monoamine oxidase inhibitor (MAOI) that has been shown to relieve depressive symptoms in patients with major depressive disorder, according to a company news release.

"Together with Bristol-Myers Squibb, we are excited to be able to utilize transdermal technology to administer Emsam, belonging to the MAOI class of agents that have proven antidepressant efficacy," Mel Sharoky, MD, Somerset president and chief executive officer, said in a statement.

Although their mechanisms of action are not fully understood, MAOIs, including Emsam, are presumed to work through potentiation of monoamine neurotransmitter activity in the brain by inhibiting the MAO enzyme, the release said.

In an in vivo animal model, Emsam exhibited antidepressant properties only at doses that inhibited both MAO-A and MAO-B in the brain. In the brain, MAO-A and MAO-B play important roles in the breakdown of neurotransmitter amines such as norepinephrine, dopamine and serotonin.

Through transdermal delivery, Emsam is absorbed into the bloodstream over a 24-hour period. As a result, initial exposure of the drug to the digestive tract is minimized, the release said.

The efficacy of Emsam in relieving depressive symptoms was established in two double-blind, placebo-controlled studies of six-week and eight-week durations that included adult outpatients, between the ages of 18 and 70, with single and recurrent episodes of major depressive disorder.

Somerset Pharmaceuticals developed Emsam, and in December 2004, Bristol-Myers Squibb and Somerset entered into an agreement that provides Bristol-Myers Squibb with exclusive distribution rights to commercialize Emsam after approval in the United States and Canada.

Bristol-Myers Squibb is a pharmaceutical and related health care products company with headquarters in New York.

Somerset Pharmaceuticals is a joint venture between Mylan Laboratories and Watson Pharmaceuticals. The company is based in Tampa, Fla.

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