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.
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.
By Stephanie Baum
Stephanie Baum is the East Coast Innovation Reporter for MedCityNews.com. She enjoys covering healthcare startups across health IT, drug development and medical devices and innovations deployed to improve medical care. She graduated from Franklin & Marshall College in Pennsylvania and has worked across radio, print and video. She's written for The Christian Science Monitor, Dow Jones & Co. and United Business Media.Visit website | More posts by Author
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