NEW YORK (TheStreet) -- Shares of Avanir Pharmaceuticals (AVNR) were down 3.26% to $12.78 in morning trading Friday after the FDA provided preliminary written feedback to the biopharmaceutical company regarding its New Drug Application (NDA) for its migraine treatment drug AVP-825.
AVP-825 is a combination drug and device that contains low-dose sumatriptan powder delivered intranasally.
The FDA has brought up concerns about the human factor validation study data submitted as part of the NDA, the company said. Human factor testing centers on the interactions between humans and devices, and the goal of the testing is to determine the risks related to device use and ensure that people can safely and effectively use the device.
The FDA requested that the company optimize the interface between device and user and conduct additional human factor testing. The FDA also said it has not completed its NDA review and additional comments could follow.