The FDA has approved Avanir Pharmaceuticals’ intranasal sumatriptan for the treatment of acute migraines, the company said. The product, which Avanir licensed from OptiNose in 2013, will be marketed in the US as Onzetra Xsail.
Avanir submitted an NDA for the product, then known as AVP-825, in January 2014 and received a complete response letter from the FDA in November 2014. At the time, the FDA expressed concerns about human factors questions related to the product’s novel OptiNose bi-directional delivery device.
Commenting on the approval, newly appointed Avanir President and CEO Rohan Palekar said, “We are excited about this major milestone for Avanir as the approval of Onzetra Xsail represents our second approved product. We expect to make Onzetra Xsail available to patients in the coming months. We continue to be focused on building a leading CNS biopharmaceutical company and the addition of Onzetra Xsail to our product portfolio takes us closer to achieving that goal.”
OptiNose President Ramy Mahmoud commented, “Our whole team is pleased and excited about this approval and about the opportunity to see migraine patients benefit from using a product based on our Bi-Directional Breath Powered technology platform. This approval highlights the ability of OptiNose to successfully bring differentiated new products that use our innovative technology to the market. We love the idea of helping people, and our team is working hard to create even more new treatments to do just that.”
OptiNose CEO Peter Miller added, “In addition to making an important treatment option available to a suffering patient population, the approval of Onzetra Xsail also provides OptiNose the ability to use the licensing proceeds to help with the research, development, and future commercialization of our next product candidate, OPN-375. If approved, we believe that OPN-375, which is a late phase pipeline asset, may play a valuable role in helping to treat patients for indications associated with chronic nasal inflammatory disease, such as nasal polyposis and chronic sinusitis. The proceeds will also help us pursue other pipeline assets in 2016.”
Read the Avanir Pharmaceuticals press release.
Read the OptiNose press release.
