Avanir Pharma: FDA Issues Prelim. Feedback On AVP-825 For Migraine

(RTTNews) - Avanir Pharmaceuticals, Inc. (AVNR) Friday said the U.S. Food and Drug Administration or FDA has raised questions regarding the human factor validation study data, filed as part a of the company's New Drug Application or NDA for AVP-825, which is indicated for the treatment of Migraine. The FDA's preliminary written feedback to its NDA for AVP-825 was provided via a discipline review letter. Also, the FDA said the NDA review is not complete and that they may have additional comments regarding the application.

AVP-825 is a drug-device combination product consisting of low-dose sumatriptan powder, delivered intranasally utilizing a novel breath powered delivery technology.

Human factor testing focuses on the interactions between people and devices and its aim is to evaluate use-related risks and confirm that users can use the device safely and effectively.

The company said that approval of AVP-825 is unlikely to happen by the PDUFA date of November, 26, 2014.