Zecuity Redesign Got Migraine Patch Through FDA, But Burning Continued

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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.

FDA thought burning and scarring effects with NuPathe Inc.'s migraine therapy Zecuity could be addressed with a redesign that added technology to ensure proper placement of the patch, but persistent adverse events reported during the battery-powered transdermal system's short time on the market suggests that the agency's confidence that the problem had been fixed was misplaced.

FDA reviewers initially opposed approval of Zecuity, an iontophoretic transdermal system that delivered the venerable migraine drug sumatriptan (GlaxoSmithKline...

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