--ONZETRA Xsail is the first breath-powered intranasal medication delivery system for the acute treatment of migraine--

Otsuka's U.S. subsidiary Avanir Pharmaceuticals, Inc. on January 28 (U.S. time) announced that the U.S. Food and Drug Administration (FDA) has approved ONZETRA^™Xsail^™ (sumatriptan nasal powder) for the acute treatment of migraine with or without aura (a sensation preceding a definitive symptom) in adults.

ONZETRA Xsail is an intranasal medication delivery system containing a low-dose (22mg) of sumatriptan powder, the most commonly prescribed migraine medication in the U.S. The medication is delivered intranasally utilizing the novel Xsail^™ Breath Powered Delivery Device and is a fast-acting, dry-powder, intranasal form of sumatriptan for the acute treatment of migraine.

The breath powered delivery technology is activated by a user's breath to propel medication deep into the nasal cavity where absorption is more efficient and consistent. The user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity. Through a sealing nosepiece placed into the nostril, the exhaled breath carries medication from the device directly into one side of the nose. Narrow nasal passages are gently expanded and medication is dispersed deep into the nasal cavity reaching areas where it can be rapidly absorbed. As the medication is delivered, the air flows around to the opposite side of the nasal cavity and exits through the other nostril. Closure of the soft palate helps prevent swallowing and reduce GI absorption.