FDA Says No To Avanir Pharma's Migraine Drug-Device AVP-825

(RTTNews) - The FDA has declined to approve Avanir Pharmaceuticals Inc.'s (AVNR) investigational drug-device combination product AVP-825 for the treatment of migraine.

AVP-825 delivers sumatriptan powder intranasally utilizing a novel Breath Powered delivery technology. The approval of AVP-825 is being sought under 505(b)(2) regulatory pathway and its NDA included data from one pivotal phase III clinical trial, a phase II placebo-controlled clinical trial and two pharmacokinetic studies for the acute treatment of migraine.

In the Complete Response Letter issued today, the FDA has requested the company to conduct a new human factors validation study to assess usability of the device following improvements. However, no additional clinical trials have been sought by the regulatory agency.

Avanir plans to conduct a new human factors study, with input from the FDA, and respond to the Complete Response Letter in the first half of calendar 2015.

AVNR closed Wednesday's trading at $15.01. In after-hours, the stock slipped 4.53% to $14.33.