WASHINGTON – The first skin patch to treat depression won federal approval Tuesday, providing a novel way to administer a drug already given to Parkinson’s disease patients. However, the drug belongs to a class of medicines that is rarely a first or second choice as an antidepressant.
The Food and Drug Administration approved the selegiline transdermal patch, agency spokeswoman Susan Cruzan said. The drug will be marketed as Emsam, said Somerset Pharmaceuticals Inc., which developed the drug, and Bristol-Myers Squib Co., which will market it in three sizes as a once-a-day treatment for major depression.
Selegiline, approved in pill form by the FDA in 1989 to help treat Parkinson’s, is a monoamine oxidase inhibitor, or MAOI. Typically, doctors prescribe MAOIs for depression only if patients don’t respond to other antidepressants, including selective serotonin reuptake inhibitors such as Prozac, Zoloft and Paxil.
Although health officials say MAOIs are safe when used correctly, the drugs can cause dangerous interactions, including sudden and severe spikes in blood pressure that can lead to stroke and death, when patients consume food or drinks that contain a substance called tyramine. The substance is found in draft beer, red wine, fava beans, salamis, aged cheeses, soy sauce and other products.
Bristol-Myers and Somerset said Emsam patients, when using the 6-milligram, or lowest-strength, patch, shouldn’t have to watch their diets.
However, patients using the larger 9- or 12-milligram versions of the Emsam patch still must adhere to the same dietary restrictions that have made many doctors reluctant to prescribe MAOIs.
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