Shares of NuPathe
(NASDAQ:PATH) are rising after the small biotech company won
US approval for its patch to treat migraine headaches.
The company won approval for Zecuity on the second try after the US Food and Drug Administration rejected the product in 2011. Zecuity is approved for the acute treatment of migraines. The battery-powered patch delivers the older drug sumatriptan
through the skin using an electrical current. The product treats headache pain and migraine-related nausea and is an alternative to already-approved oral, nasal, and injected medicines.
Shares of the company rose 19% to $3.94 in pre-market trading Friday. The product was approved Thursday evening. The stock rose more than 40% in the 12 months leading up to the approval.
Zecuity actually won’t be on the market until the fourth quarter as the company needs time to make the patches, CEO Armando Anido says in an interview with Minyanville.
“Starting (Friday) the manufacturing group will be up and running,” he says.
Anido also plans to find a marketing partner to help sell the product. The ideal partner would have experience selling to primary care doctors, he says. For its marketing efforts, NuPathe is targeting doctors who are headache specialists, including many primary care physicians, he says. The company will also market to neurologists.
The FDA initially rejected the patch in part due to concern about skin irritations. The company made adjustments to design of the product (previously known as Zelrix) to address the agency’s concerns. Zecuity’s label includes a warning about a possible serious skin reaction. See full prescribing information here
Anido said an announcement about price of the product would be made closer to a sales launch of Zecuity. But he noted that an injected treatment, Zogenix’s
(NASDAQ:ZGNX) Sumavel, for acute migraine headaches sells for $95 a dose and that NuPathe’s patch would be priced in that ballpark. Zecuity is a single-use patch.
More than 30 million Americans suffer from migraines, Anido says. But only about 16 million are diagnosed and treated, he says. About half of those diagnosed treatments would be prime targets for Zecuity prescriptions, Anido estimates.
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