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Parkinson's skin patch OK'd as antidepressant
March 1, 2006
ASSOCIATED PRESS
The first skin patch to treat depression won federal approval yesterday,
providing a novel way to administer a drug already used by Parkinson's
patients but that belongs to a class of medicines that is rarely a first- or
second-choice antidepressant.
The Food and Drug Administration (FDA) 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 Squibb Co., which will market it in three sizes as a once-a-day
treatment for major depression.
"We believe Emsam will help physicians treat their patients living with
this illness through a new and unique delivery system," said Peter Dolan,
chief executive officer of Bristol-Myers Squibb.
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 rises 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, salami, aged cheeses, soy sauce and other
products.
Bristol-Myers and Somerset said Emsam patients, when using the
six-milligram or lowest-strength patch, shouldn't have to watch their diets.
That represents a "significant advance" over other MAOIs typically taken in
pill form, said Dr. Steven Galson, director of the FDA's Center for Drug
Evaluation and Research.
However, patients using the larger nine- 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.
The Emsam patch's label will carry a long list of foods, drinks and other
drugs that patients must avoid while using the drug. The warnings are typical
of all MAOIs.
The FDA also will require the drug to bear a so-called "black-box" warning
of the risks of suicidal thoughts and behaviors in children and adolescents
treated with antidepressants. The drug is meant for use only by adults.
Somerset Pharmaceuticals is a joint venture between Watson Pharmaceuticals
Inc. and Mylan Laboratories Inc.
The companies said 14 million Americans a year suffer from major
depression, citing a 2003 Journal of the American Medical Association study.
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