The US Food and Drug Administration (FDA) has declined approval for a drug-device product combining low-dose sumatriptan powder delivered intranasally using a novel delivery technology for the treatment of migraine (AVP-825, Avanir Pharmaceuticals Inc), the company reports.
“In the Complete Response letter (CRL), 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,” a statement from Avanir released November 26 notes.
Human factors testing evaluates use-related risks and confirms that users can use the device safely and effectively, the statement said. “A new human factors validation study will be required to assess usability of the device following improvements.”
The FDA didn’t find any clinical or nonclinical safety or efficacy issues, or any chemistry, manufacturing, and controls issues, the release adds, nor did the agency request any additional clinical trials be conducted before approval.
“We believe the concerns raised by the FDA are fully addressable,” said Joao Siffert, MD, chief medical officer of Avanir in the company statement. “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.”
AVP-825 is an investigational drug-device combination product consisting of low-dose (22 mg) sumatriptan powder delivered intranasally using a novel breath-powered delivery technology that is activated by the user’s breath to “propel medications deep into the nasal cavity where absorption is more efficient and consistent,” the company statement notes.