ARTICLE | Clinical News

Intranasal sumatriptan powder regulatory update

November 10, 2014 8:00 AM UTC

On Nov. 7, Avanir said FDA is "unlikely" to approve an NDA for AVP-825 to treat migraines by its Nov. 26 PDUFA date based on preliminary written feedback from the agency. Avanir said FDA raised questions in a discipline review letter regarding the human factor validation study (data that focuses on the interactions between people and devices) submitted in the NDA. The agency asked the company to optimize the product-user interface and conduct additional human factor testing. ...