The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for AVP-825, an innovative closed-palate Breath Powered™ investigational drug-device combination product for the acute treatment of migraine.
As previously reported, the 505(b)(2) NDA for AVP-825 includes clinical data developed by OptiNose including a pivotal phase III controlled clinical trial, a supportive phase II controlled clinical trial and two pharmacokinetic studies. The NDA also references data from the extensive clinical use of sumatriptan over the past 20 years.
The acceptance of the NDA indicates that the application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act (PDUFA) V goal date is November 26, 2014.