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Avanir announced that Onzetra Xsail (sumatriptan nasal powder) is now available to treat acute migraines with or without aura in adults.
Onzetra Xsail was approved by the Food and Drug Administration (FDA) in January 2016, based on data from Phase 2 and 3 trials involving over 300 patients plus reference data from the past 20 years on the use of sumatriptan, a serotonin 5-HT1B/1D receptor agonist.
Onzetra Xsail is a fast-acting dry-powder intranasal form of sumatriptan. The Breath Powered delivery technology relies on the user’s breath to propel medication into the nasal cavity where absorption is efficient and consistent. The user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity while dosing. 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 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.
The most common adverse reactions seen in clinical trials (≥ 2% and > placebo) were abnormal taste, nasal discomfort, rhinorrhea, and rhinitis.
Onzetra Xsail is available in 8 dose kits; each pouch contains 2 nosepieces (each containing 11mg of sumatriptan) and 2 breath-powered delivery system bodies.
For more information call 1-844-669-3872 or visit onzetra.com.
