Avanir Pharmaceuticals, Inc. (AVNR) announced the U.S. FDA has accepted the company's New Drug Application (NDA) of AVP-825, its Breath Powered investigational drug-device combination product for the acute treatment of migraine. The Prescription Drug User Fee Act (PDUFA) V goal date is November 26, 2014. The comapny said the acceptance of the NDA indicates that the application is sufficiently complete to permit a substantive review.
The company's 505(b)(2) NDA for AVP-825 includes data from one pivotal phase III clinical trial for the acute treatment of migraine. The NDA is also supported by data from a phase II placebo-controlled clinical trial for acute treatment of migraine, and two pharmacokinetic studies. Overall, the NDA includes safety data from 222 subjects who received AVP-825 in clinical trials, and references data from the extensive clinical use of sumatriptan over the past 20 years.
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