Migraine sufferers (and no doubt some investors) will be feeling some relief tonight after NuPathe (NASDAQ: PATH) secured approval from the U.S. Food and Drug Administration for its lead product — the first skin patch to deliver sumatriptan, a widely used migraine medication. The delivery system is aimed at people who get migraines and experience nausea.
Zecuity is a battery-powered patch that delivers sumatriptan through the skin with a mild, electrical current referred to as iontophoresis.
About 8 million people in the U.S. suffer migraine-related nausea.
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The approval for the Zecuity came more than a year after the Conshohocken, Pennsylvania-based company’s initial submission was met with a complete response letter from the U.S. Food and Drug Administration that required the company to do additional testing and design modifications before resubmitting Zecuity for approval last year. Since then, Jane Hollingsworth, the co-founder of the biopharmaceutical company, resigned and was replaced with Armando Anido, who had taken over as CEO of Hollingsworth’s previous company Auxilium Pharmaceuticals (NASDAQ: AUXL).
NuPathe has begun searching for a commercial partner as the company prepares to bring the drug-delivery system to market in the fourth quarter. In a conference call this morning, the company said it would be doing further studies this year and in 2014 to provide additional clinical data to the FDA.
