Avanir Pharmaceuticals, Inc. (AVNR) announced it has submitted a New Drug Application (NDA) to the U.S. FDA for approval of AVP-825, its Breath Powered investigational drug-device combination product for the acute treatment of migraine. 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.
AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder delivered intranasally utilizing a Breath Powered delivery technology.
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