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.
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.
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