According to Avanir Pharmaceuticals, it has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for AVP-825 intranasal sumatriptan for the treatment of migraine. The company had recently warned that its NDA was unlikely to be approved by the PDUFA date due to FDA concerns about human factors issues.
In the CRL, “the FDA requested that Avanir assess the root cause(s) of device use errors observed in the previously conducted human factors testing,” the company said, and the FDA is requiring a new human factors validation study to assess the usability of a modified device. AVP-825 is delivered using OptiNose’s Breath Powered delivery device.
Avanir Chief Medical Officer Joao Siffert said, “We believe the concerns raised by the FDA are fully addressable. Following the receipt of the preliminary feedback we have been working internally and with the FDA toward implementing changes prior to repeating the human factors study. Based on these conversations, we will conduct a new human factors study, with input from the FDA, with a goal to respond to the CRL in the first half of calendar 2015.”
Read the Avanir press release.
