Antidepressant Skin Patch Receives FDA’s Approval
Bristol-Myers Squibb Co. and a joint venture including Corona-based drug maker Watson Pharmaceuticals Inc. won final U.S. approval Tuesday for the first skin patch to deliver antidepressant medication.
Called Emsam, the once-daily patch delivers a medication used for hard-to-treat patients with depression, and is not likely to be the first choice of doctors, experts said. It was approved by the Food and Drug Administration only for adults and will bear a warning of increased risk of suicide in children and adolescents.
Patients taking higher doses of the Emsam patch will have to follow strict dietary guidelines, but those taking the lowest dose will be free to eat cheese, smoked meats and other foods usually restricted with similar antidepressants.
Like other monoamine oxidase inhibitors, Emsam can carry the risk of high blood pressure if patients eat those and other foods containing the compound tyramine.
The patch is made by Somerset Pharmaceuticals Inc., a joint venture of Watson and Mylan Laboratories Inc. Bristol-Myers Squibb has U.S. marketing rights for the patch.
The FDA conditionally approved the patch in 2004.
‘Shares of Mylan closed off 67 cents at $23, while Watson fell 38 cents to $29.98. Shares of Bristol-Myers fell 11 cents to $23.10.
Reuters and Bloomberg News were used in compiling this report.
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