FDA issues Complete Response Letter for OptiNose BDS for Migraine-Avanir Pharma

The FDA has issued a Complete Response letter to the New Drug Application (NDA) for the OptiNose Bi-Directional System, or AVP 825 (low-dose sumatriptan), from Avanir Pharma, for Migraine. In the Complete Response letter, and consistent with the preliminary feedback announced on November 7, 2014, the FDA requested that Avanir assess the root causes of device-use-errors observed in the previously conducted human factors testing. The goal of human factors testing is to evaluate use-related risks and confirm that users can use the device safely and effectively.

A new human factors validation study will be required to assess usability of the device following improvements. The FDA did not find any clinical or non-clinical safety or efficacy issues nor chemistry, manufacturing, and controls issues. The FDA did not request that any additional clinical trials be conducted prior to approval. The company plans to respond to the CRL in the first half of calendar 2015.