OptiNose, a privately-held specialty biopharmaceutical company, announced that its licensing partner, Avanir Pharmaceuticals, Inc. has reported that the U.S. Food & Drug Administration (FDA) approved ONZETRA™ Xsail™ (sumatriptan nasal powder), formerly AVP-825, for the acute treatment of migraine with or without aura in adults. ONZETRA Xsail is the first product developed by OptiNose to receive FDA approval and is an intranasal medication delivery system using the novel Xsail Breath Powered Delivery Device.
The Xsail device is based on OptiNose’s unique and patented Bi-Directional Breath Powered technology platform and delivers a low dose of sumatriptan powder into the nose in a new and different way.
After completing Phase III development, OptiNose out-licensed the North American commercialization and further development rights for ONZETRA Xsail to Avanir Pharmaceuticals, Inc. (a subsidiary of Otsuka America, Inc.). Under the terms of the licensing agreement, OptiNose receives upfront and milestone payments collectively valued at up to $110 million and tiered double digit royalty payments based on net sales.
