NuPathe Wins U.S. FDA Approval for Migraine Skin Patch
NuPathe Inc. (PATH), a maker of neurological and psychiatric medicines, won U.S. approval to sell the first skin patch to treat migraines.
The Food and Drug Administration cleared the treatment, called Zecuity, which delivers sumatriptan, the most-prescribed migraine headache medication, through a mild electrical current, Conshohocken, Pennsylvania-based NuPathe said yesterday in a statement.
“We anticipate the product will be available for sale in the fourth quarter of this year,” Armando Anido, NuPathe’s chief executive officer, said in an interview. “We’re right now in conversations with a number of people for partnership in the United States.”
In August 2011, the FDA decided against approving the therapy, saying that while it was effective, the regulatory body had questions about the patch’s safety, Anido said. The company has since redesigned it.
“It was actually related to some signals around skin reactions,” he said. “The company went through extensive work to make adjustments to the patch in order to make it safe and make sure these reactions never happen again.”
A migraine is a neurological disorder that affects about 31 million adults in the U.S., Anido said. In addition to headache pain, patients suffer from nausea and vomiting.
Anido declined to say how much the patch would cost, though he indicated it would be comparable to the $95 that a similar medication costs as an injection.
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