Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response letter to its New Drug Application (NDA) for AVP-825. AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder delivered intranasally utilizing a novel Breath Powered delivery technology.
In the Complete Response letter, and consistent with the preliminary feedback announced on November 7, 2014, the FDA requested that Avanir assess the root cause(s) 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 (CMC) issues. The FDA did not request that any additional clinical trials be conducted prior to approval.
"We believe the concerns raised by the FDA are fully addressable," said Joao Siffert, MD, chief medical officer of Avanir. "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."
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