First depression patch approved

FDA Consumer, May-June, 2006

The FDA has approved the first skin (transdermal) patch, called Emsam (selegiline), for treating major depression.

Emsam is a once-a-day patch that delivers selegiline, a monoamine oxidase inhibitor, or MAOI, through the skin and into the bloodstream. Its three layers consist of a backing, adhesive drug layer, and release liner that is placed against the skin.

"Emsam provides a significant advance," says Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research, "because at least in its lowest dose, patients can use the drug without the usual dietary restrictions associated with these types of drugs known as MAO inhibitors." The lowest dose of the MAOI patch delivers 6 milligrams (mg) of the medication over a 24-hour period.

MAOIs usually require specific dietary restrictions because when combined with certain foods, they can cause a sudden, large increase in blood pressure, or hypertensive crisis, which can lead to a stroke and death. Symptoms of a hypertensive crisis include sudden severe headache, nausea, stiff neck, fast heartbeat or a change in the way the heart beats, sweating, or confusion. Patients who have these symptoms must get medical attention immediately.

The Emsam patch, which will be distributed by the New York-based Bristol-Myers Squibb, will be available in three sizes that deliver 6 mg, 9 mg, or 12 mg of selegiline over 24 hours.