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Onzetra Xsail FDA Approval History

FDA Approved: Yes (First approved January 27, 2016)
Brand name: Onzetra Xsail
Generic name: sumatriptan
Dosage form: Inhalation Powder
Previous Name: AVP-825
Company: Avanir Pharmaceuticals, Inc.
Treatment for: Migraine

Onzetra Xsail (sumatriptan) is a fast-acting, intranasal serotonin 5-HT1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura.

The approval of Onzetra Xsail is based on data from the TARGET trial of 230 migraine sufferers who self-administered either Onzetra or placebo using the Xsail Breath Powered Delivery Device when experiencing moderate to severe migraine pain. Study results demonstrated that a significantly greater proportion of Onzetra Xsail patients reported headache relief at 30 minutes and at every time point up to two hours post-dose compared with those using the placebo device.

The recommended dose of Onzetra Xsail is 22 mg, administered by use of one nosepiece (11 mg) in each nostril, with a maximum of two doses in any 24-hour period. A dose is delivered when 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 and deep into the nasal cavity where absorption is more efficient and consistent. Closure of the soft palate helps prevent swallowing and reduce GI absorption.

The most common side effects reported include abnormal product taste, nasal discomfort, rhinorrhea, and rhinitis.

Development timeline for Onzetra Xsail

Jan 28, 2016Approval FDA Approves Onzetra Xsail (sumatriptan nasal powder) for the Acute Treatment of Migraine
Nov 26, 2014Avanir Pharmaceuticals Receives Complete Response Letter (CRL) from FDA on AVP-825 NDA
Nov  7, 2014Avanir Pharmaceuticals Announces Preliminary Feedback from the FDA on AVP-825 for the Acute Treatment of Migraine
Oct 30, 2014Avanir Pharmaceuticals Announces Publication of Pivotal Phase III Results from AVP-825 Acute Migraine Study
Mar 26, 2014Avanir Pharmaceuticals Announces Acceptance of NDA for AVP-825 for the Acute Treatment of Migraine
Jan 30, 2014Avanir Pharmaceuticals Announces Submission of New Drug Application for AVP-825 for the Acute Treatment of Migraine

Further information

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