According to Avanir Pharmaceuticals,the FDA has issued a Discipline Review letter in response to the company’s NDA for AVP-825 intranasal dry powder sumatriptan requesting that the company “optimize the product-user interface” and conduct additional human factor testing. AVP-825 is delivered using OptiNose’s Breath Powdered intranasal delivery device.
Although the FDA is continuing to review the NDA, Avanir says, approval is unlikely by the November, 26, 2014 PDUFA date. The 505(b)(2) NDA for the product was initially filed in January 2014.
Avanir Chief Medical Officer Joao Siffert commented, “We are currently reviewing the correspondence from the FDA and are awaiting the final feedback when the full NDA review cycle is complete on November 26th. We plan to work closely with the FDA to answer the agency’s questions and satisfy their requirements. We remain confident that AVP-825 will be an important new treatment option for migraine patients who are in need of alternative, fast acting and well tolerated medications.”
Read the Avanir press release.
