Avanir Pharmaceuticals has announced that the FDA has accepted its new drug application for the company’s AVP-825 dry powder intranasal sumatriptan for the treatment of migraine headaches. The 505(b)(2) NDA was filed in January 2014.
According to Avanir, the PDUFA goal date is November 26, 2014.
AVP-825 was developed by OptiNose for delivery using OptNose’s breath-powered nasal delivery device. Avanir announced in July 2013 that it had paid OptiNose $20 million up front plus up to $90 million in milestone payments for North American rights to the product.
Read the Avanir press release.
