Ninety percent of migraine sufferers experience nausea, while 60 percent experience vomiting because of their migraine. As a result, today’s most common migraine treatments that are administered orally are less effective. Enter Zelrix, or NP101, which uses a transdermal patch to deliver an efficacious amount of sumatriptan—the gold standard for migraine drugs—to avoid gastrointestinal complications.
After market close yesterday, NuPathe (Nasdaq: PATH) announced its third quarter 2011 financial results and some recent operational highlights. Included in those highlights was an update on the status of Zelrix.
In its report, NuPathe reported it made considerable progress towards resolving the questions arising from the FDA’s Complete Response Letter (CRL) received on August 29, 2011. Last week, on November 9th, NuPathe met with the FDA to discuss the CRL, confirming its research approach and the data that needs to be addressed.
During NuPathe’s conference call for investors, the company announced plans to resubmit a New Drug Application (NDA) to the FDA in the first half of 2012. In the interim, NuPathe will continue its launch preparation, including efforts to broaden physician awareness of a solution to the challenge of migraine-related nausea.
At the close of the third quarter conference call, NuPathe CEO Jane Hollingsworth reiterated some very important points that she also made during her presentation at Safeguard Scientifics’ Investor Day 2011. Specifically, she emphasized the need for a more effective migraine treatment sensitive to gastrointestinal complications. Addressing this need will drive NuPathe’s success and create value in the company.
About seven million patients in the U.S. alone have nausea to the point where it affects their ability to treat their migraine, paving the way for a partner who can directly address this unmet need in the marketplace. Take a look at the following Investor Day video featuring Hollingsworth to hear more about NuPathe’s migraine patch, potential market opportunity, and growth opportunity. a