FDA Issues Complete Response Letter for Acute Migraine Treatment

Avanir Pharmaceuticals announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to its New Drug Application (NDA) for AVP-825, its Breath Powered investigational drug-device combination product for the acute treatment of migraine. AVP-825 consists of intranasally delivered low-dose sumatriptan powder.

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In the Complete Response letter, the FDA requested that Avanir assess the root cause(s) of device use errors observed in the previously conducted human factors testing. 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 (CMC) issues. The FDA did not request that any additional clinical trials be conducted prior to approval.

For more information call (855) 468-3339 or visit Avanir.com.