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  5. Otsuka's Subsidiary Avanir Pharmaceuticals Announces U.S. FDA Approval of ONZETRAXsail for the Acute Treatment of Migraine in Adults

January 29, 2016

Otsuka Pharmaceutical Co., Ltd.


Otsuka's Subsidiary Avanir Pharmaceuticals Announces U.S. FDA Approval of ONZETRAXsail for the Acute Treatment of Migraine in Adults

--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 ONZETRAXsail (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.

About Avanir Pharmaceuticals, Inc.

Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of their commitment, Avanir has extensively invested in their pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit
Avanir is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd.

Information in this news release was current as of the original release date.

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