The FDA has handed NuPathe a complete response letter detailing demands for new information on its experimental migraine patch, Zelrix (NP101). But even after scrambling to try and reassure investors that it could move quickly to respond to the agency, investors fled the scene, wiping out half of the biotech's stock value ($PATH) in a matter of minutes.
NuPathe said in a release that the FDA had been satisfied about the efficacy of Zelrix, but raised questions regarding "chemistry, manufacturing and safety questions." The developer also said that it may mount Phase I and other non-clinical studies to address "other questions." And the CEO adopted a stiff upper lip in declaring the company's plans to forge ahead.
"This CRL gives us confidence that we can provide the information needed to support FDA approval for our migraine patch in a timely manner," said Jane Hollingsworth, CEO of NuPathe. "We continue to believe that our patch will address the symptoms of millions of patients who suffer from debilitating migraine headache pain and migraine-related nausea. We look forward to working with the FDA to bring this important product to market."
The patch itself is designed to provide a new delivery route for sumatriptan, a widely used migraine treatment. By bypassing the GI tract, NuPathe believed it could also skirt some of the common side effects of the drug.
- here's the NuPathe release