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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Business News
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.