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FDA Approves Onzetra Xsail for Migraine in Adults

Intranasal medication for treatment of migraine

Publish date:: February 16, 2016

Avanir Pharmaceuticals, Inc. announced that the US Food and Drug Administration (FDA) has approved Onzetra Xsail (sumatriptan nasal powder), formerly known as AVP-825, for the acute treatment of migraine with or without aura in adults.

Indication: Onzetra Xsail is indicated for the acute treatment of migraine with and without aura in adults. It is not indicated for the prevention of migraine attacks.

Dosage/administration: Onzetra Xsail is an intranasal medication delivery system consisting of a low-dose (22 mg) of sumatriptan powder that is delivered utilizing the novel Xsail Breath Powered Delivery Device.

Adverse reactions: In clinical trials, the most common adverse reactions (≥ 2% and > placebo) were abnormal taste, nasal discomfort, rhinorrhea, and rhinitis.

Citation: Avanir Pharmaceuticals announces FDA approval of ONZETRA™ Xsail™ (AVP-825) for the acute treatment of migraine in adults. [news release]. Aliso Viejo, CA: Avanir Pharmaceuticals; January 28, 2016: http://www.avanir.com/press/avanir-pharmaceuticals-announces-fda-approval-onzetra%E2%84%A2-xsail%E2%84%A2-avp-825-acute-treatment-migraine. Accessed February 4, 2016.

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