NuPathe Must Patch Together New Zelrix Launch Timetable After "Complete Response" Letter
This article was originally published in The Pink Sheet Daily
FDA had questions related to chemistry, manufacturing and safety of migraine patch, company said.
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FDA worries about burning and scarring with the battery-powered Zecuity patch prompted NuPathe to reconfigure the drug-device combo; our Drug Review Profile shows how FDA thought the problem was solved, but adverse reaction reports soon after launch led to marketing suspension.
Fate of migraine patch remains uncertian after 'large number' of patients suffer burns and scars; adverse event was issue during review of transdermal sumatriptan product, but didn't even make it into labeling; nine months later the problems have forced Teva to suspend marketing.
Allergan/MAP Planned Merger, Approval Of NuPathe’s Triptan Patch Change U.S. Landscape For Migraine Therapy
While Allergan plans to diversify its portfolio in migraine by acquiring partner MAP and its candidate for acute migraine, NuPathe seeks a partner for a triptan patch product expected to avoid the nausea suffered by many migraine patients.