NuPathe ($PATH) crossed the regulatory finish line with FDA approval of its migraine patch, Zecuity, overcoming the agency's concerns about the battery-powered delivery system that prompted a denial from U.S. regulators in 2011.
The Conshohocken, PA-based company's shares jumped on the FDA nod for Zecuity and were up 7.9% to $3.56 as of 10:26 am ET on Friday. This isn't the kind of product that anyone would likely deem revolutionary because it's a new way of delivering an old drug, but the company's $52.3 million market cap speaks to how much value investors are placing on it.
Still, the product is the first patch approved to deliver the widely prescribed migraine drug sumatriptan through the skin, and the company showed in clinical trials that the product reduced cases of nausea associated with the standard oral form of the migraine med. By delivering sumatriptan through the skin, the product keeps the drug away from the gut, according to the company. The company says this is important because roughly half of the 16 million migraine sufferers in the U.S. experience nausea and avoid oral meds for their headaches.
The FDA shot down the company's previous application for Zecuity in August 2011 over concerns about the safety of the delivery patch related to skin reactions, Bloomberg reported. The company redesigned the system to address the issue.
"We anticipate the product will be available for sale in the fourth quarter of this year," Armando Anido, NuPathe's CEO, told Bloomberg. "We're right now in conversations with a number of people for partnership in the United States."
- here's the release
- see Bloomberg's article