OptiNose submits NDA to FDA

The FDA has accepted OptiNose's new drug application for the drug/device combination product candidate AVP-825 for the treatment of headaches. It uses the company's Bi-Directional Breath Powered technology to deliver a low dose of sumatriptan powder into the nose. "From the beginning, we believed our innovative drug delivery approach would make it possible to significantly improve the clinical care of common diseases--and this study further supports that. We are pleased that the publication of these results, along with the results of the COMPASS trial, offers emerging evidence of this product's efficacy alone and in comparison to the current 'gold standard' of migraine treatment," said Dr. Ramy Mahmoud, the president of OptiNose. Release