ONZETRA Xsail Receives FDA Approval for Acute Migraine

The U.S. 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.1 ONZETRA Xsail is a low-dose sumatriptan powder delivered intranasally using a unique Xsail breath powered delivery device.

This exhaler device uses the natural function of a patient’s breath to help deliver the medication beyond the nasal valve into deep areas of the nasal cavity. The patient exhales into the device, naturally closing the soft palate and sealing off the nasal cavity from the throat. The exhaled breath carries medication from the device into one side of the nose through a specially shaped sealing nose piece, balancing the pressure on the soft palate. The narrow nasal passages are expanded and medication is transported beyond the nasal valve to targeted sites. After it is delivered to these sites, air flows around to the opposite side of the nasal cavity and exits through the other nostril.

ONZETRA Xsail was approved for the acute treatment of migraine based on data from several clinical trials. A total of 230 patients with migraine participated in the TARGET trial,  and were randomly assigned to self-administer the sumatriptan powder or placebo using the Xsail delivery device when they were experiencing moderate to severe migraine pain. Results of this study showed that a significantly greater proportion of patients who received active treatment reported headache relief at 30 minutes and at every time point up to 2 hours compared with those using the placebo device.

The most common adverse reactions associated with the use of ONZETRA Xsail were abnormal taste, nasal discomfort, rhinorrhea, and rhinitis.

ONZETRA Xsail is indicated for the acute treatment of migraine with or without aura in adults. It is not indicated for the prevention of migraine attacks and it’s safety and effectiveness has not been determined for the treatment of cluster headaches.

ONZETRA Xsail provides an additional treatment option for people with migraine, and may be helpful in those who may experience side effects taking certain oral medications.

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