Avanir Pharma files NDA for migraine drug AVP-825

US drugmaker Avanir Pharmaceuticals (Nasdaq: AVNR) has submitted a New Drug Application to the US Food and Drug Administration for approval of AVP-825, its Breath Powered investigational drug-device combination product for the acute treatment of migraine.

The company's 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 submission 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.

"The AVP-825 NDA submission represents an important milestone for Avanir, " said Joao Siffert, scientific officer at Avanir, adding: "If approved by the FDA, AVP-825 could meet a key unmet need by providing patients with a unique device that efficiently delivers a low dose of sumatriptan powder, providing rapid relief of migraine headache, coupled with good tolerability."