In August 2011, when the FDA handed NuPathe ($PATH) a complete response letter for its transdermal migraine patch, NP101, the company's stock price halved almost instantly. Now the company has announced a resubmission, and its shares climbed 8% Tuesday on the news, according to MarketWatch.
NuPathe's NP101 is a single-use, transdermal patch based on the company's SmartRelief delivery system, which uses a small electric charge to get the drug across the skin (iontophoresis). The patch, which has been referred to as Zelrix in the past, delivers sumatriptan, and its approval could make it the first transdermal patch available for the treatment of migraine.
"Resubmission of the NDA for our migraine patch is an important milestone for NuPathe," said Jane Hollingsworth, NuPathe's CEO. The submission includes additional Phase I studies, a usability study and a packaging improvement, and the company expects a 6-month review by the FDA.
NP101's market share could include patients who avoid oral medication because of migraine-related nausea, and those whose symptoms include gastroparesis, a slowing of gastric absorption that affects their response to oral drugs.
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Note from editor: Includes additional details of resubmission