ARTICLE | Clinical News

Intranasal sumatriptan powder regulatory update

December 22, 2014 8:00 AM UTC

FDA issued a complete response letter to AVP-825 from Avanir to treat migraines. The company said the letter is in line with a discipline review letter issued by the agency last month (see BioCentury, Nov. 10). According to Avanir, FDA is requesting that the biotech assess the root causes of device use errors observed in its human factors testing and conduct an additional human factors validation study to assess usability of the device following improvements. FDA did not find any clinical or non-clinical safety or efficacy issues or CMC issues. Avanir hopes to respond to the letter next half. ...