NuPathe (NASDAQ:PATH), a biopharmaceutical company, has resubmitted a new drug application for its migraine patch to the U.S. Food and Drug Administration after resolving issues raised in a complete response letter last year.
The Zelrix transdermal patch is designed to transmit sumatriptan via electrical charge through the skin in a drug-delivery method known as iontophoresis. The method, designed to speed up the delivery process, was chosen since one symptom migraine headache sufferers experience is nausea, which makes oral medication a challenge.
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Jane Hollingsworth, NuPathe’s CEO, said she expects a six-month review by the FDA.
“With the additional data and enhancements made to the patch, we have submitted a strong application and have an even more attractive commercial opportunity designed to address the needs of the nearly half of migraine patients who frequently experience both headache pain and migraine-related nausea,” a company statement said.
Among the Conshohocken, Pennsylvania company’s investors are Quaker BioVentures, which holds a 22 percent stake; Safeguard Scientifics (NYSE:SFE); Battelle Ventures; and GlaxoSmithKlein‘s (NYSE:GSK) venture capital arm, SROne.
