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news.The New Drug Application (NDA) filed by NuPathe for its transdermal sumatriptan migraine patch (Zelrix), has been rejected by the FDA over chemical make-up and manufacturing issues.
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According to FDA, the data provided by the company was insufficient regarding migrane indication, painmedicinenews.com reported.
NuPathe conducted a Phase III trial testing the efficacy of the transdermal patch, which showed that 70% of subjects reported no nausea, a common adverse event seen with oral triptans.
The company said it will provide additional information to the FDA.