FDA approves patch to treat adult depression
February 28th, 2006 by RespiteMatch.comLast Update: 12:22 PM ET Feb 28, 2006
(Adds information on depression in fourth paragraph and analyst estimate in ninth paragraph.)
WASHINGTON (MarketWatch) — The U.S. Food and Drug Administration approved a new delivery system for a drug to treat depression in adults.
The agency approved a patch by Bristol-Myers Squibb Co. (BMY) and Somerset Pharmaceuticals Inc., the companies announced Tuesday. Somerset Pharmaceuticals is a joint venture between Mylan Laboratories Inc. (MYL) and Watson Pharmaceuticals Inc. (WPI). The patch is not approved to treat depression in children 17 and younger. The product will be sold under the brand name Emsam.
“We are pleased to be able to provide this important treatment to people with major depressive disorder,” Peter R. Dolan, Bristol-Myers’ chief executive, said in a statement. “We believe Emsam will help physicians treat their patients living with this illness through a new and unique delivery system.”
Emsam is designed to interact with three neurotransmitters in the brain that are believed to be involved with depression. About 14.8 million U.S. adults suffer from major depression in a given year and is leading cause of disability among adults, according to the National Institute of Mental Health.
The patch gained final FDA approval about two years after the agency first said the patch was “approvable.” Part of what held up final approval was the need to work out potential interactions with food and beverages.
At issue is whether patients could have an adverse reaction if they consume foods high in tyramine, such as aged cheese, salami and, to a lesser extent, beer and wine while wearing the patch. The concern is that the active ingredient in the drug, selegiline, could interact with tyramine - a substance formed from the breakdown of protein as food ages - and cause a sudden, sharp increase in blood pressure.
For patients using the patch at the lowest dose - 6 milligrams per 24 hours - they will not have to adhere to any dietary restrictions. Patients using the higher 9 and 12 milligram patches will be advised to avoid foods high in tyramine. About 14.8 million U.S. adults suffer from major depression in a given year, according to the National Institute of Mental Health and is leading cause of disability among adults.
Last year an FDA panel of outside medical experts put together to discuss the patch said they believed the patch would be safely marketed at the lowest dose without any dietary restrictions but recommended the restrictions at the two higher doses.
Analysts at Cowen & Co. estimate Emsam will have annual sales of $40 million this year that should grow to about $135 million by 2009.
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