Conshohocken, PA – NuPathe Inc., which completed an initial public stock offering two months ago, is on track to seek approval for its experimental migraine headache treatment before the end of the year.
Zelrix is a transdermal patch designed to deliver Sumatriptan, a widely prescribed migraine medication, using the company’s proprietary SmartRelief technology.
That drug-delivery technology uses iontophoresis — a noninvasive method of transporting molecules through the skin using a mild electrical current — to control both the amount and rate of medication delivery for compounds such as Sumatriptan that cannot be passively delivered through the skin.
“Our main objective, post-IPO, is to get the new drug application (NDA) done,” said CEO and co-founder Jane Hollingsworth. “Our team is working very hard to do that. There’s no easy way to do an NDA, but we feel comfortable saying it will be filed during the fourth quarter.”
Hollingsworth said the company is awaiting data from a safety trial and other clinical information requested by the FDA before it can file its new drug application.
The company, which has 25 employees, has started building the infrastructure needed for the commercial launch of Zelrix. Hollingsworth said they plan to hold off assembling a sales team until FDA approval is secured.
NuPathe’s $50 million IPO raised about $43 million in net proceeds for the Montgomery County company.
“With the addition of the net proceeds from the IPO, we believe we now have the financial strength necessary to focus on our primary objectives, most notably gaining FDA approval for Zelrix for the treatment of acute migraine,” Hollingsworth said. “We remain on track to submit our new drug application for Zelrix with the U.S. Food and Drug Administration in the fourth quarter of 2010.”
NuPathe ended the second quarter with cash and cash equivalents of about $51.5 million — sufficient to fund operations through the first half of 2012.
NuPathe’s stock is trading at about $6.22 per share, down almost $3 from its IPO price of $10 a share.