NuPathe, Inc. announced that the US Food and Drug Administration (FDA) has approved Zecuity (sumatriptan iontophoretic transdermal system) for the acute treatment of migraine with or without aura in adults. Zecuity, a single-use, battery-powered patch, actively delivers sumatriptan through the skin. Zecuity provides relief to both migraine headache pain and migraine-related nausea (MRN).
The regulatory approval was based on data from an extensive development program comprising phase III trials. The program included 800 patients using more than 10,000 Zecuity patches. Zecuity treated twice the number of patients than placebo. Moreover, 53% of the patients in the Zecuity arm achieved relief from headache as compared to 29% in the placebo arm. 84% of patients in the Zecuity arm were nausea free at two hours as compared to 63% of the patients treated with placebo. This study proved Zecuity to be safe and effective in treating migraine and relieving its cardinal symptoms two hours after patch activation.
NuPathe is currently looking for a commercial partner and expects to launch the drug in the fourth quarter of 2013.
GlaxoSmithKline plc’s (GSK) Imitrex is also approved for the treatment of migraine with or without aura in adults.
We are positive on the FDA approval as Zecuity is the first and only FDA-approved migraine patch. Zecuity’s regulatory path in the US has not exactly been smooth with the company receiving a complete response letter from the FDA in Aug 2011. Therefore, Zecuity’s approval is a major milestone for NuPathe.
We currently have a Neutral recommendation on NuPathe, Inc. With Zecuity gaining FDA approval, we expect the company to announce a partnership deal shortly. The stock carries a Zacks Rank #3 (Hold). Right now, Valeant Pharmaceuticals International, Inc. (VRX - Analyst Report) displays better fundamentals and looks more attractive with a Zacks Rank #1 (Strong Buy).