General Information

Onzetra Xsail is a nasal powder formulation of sumatriptan, a serotonin 5-HT1B/1D receptor agonist.

Onzetra Xsail is specifically indicated for the acute treatment of migraine with or without aura in adults.

Onzetra Xsail is supplied as a powder for intranasal administration, delivered with the Xsail breath-powered delivery device only. The recommended dose is 22 mg, administered by use of one nosepiece (11 mg) in each nostril. The maximum dose in a 24-hour period should not exceed two doses (44 mg) separated by at least 2 hours.

Clinical Results

FDA Approval

The FDA approval of Onzetra Xsail was based on a multicenter, randomized, double-blind, placebo-controlled study in subjects with moderate to severe migraine headache. The proportion of patients who had headache relief defined as a reduction from moderate or severe pain to mild or no pain was assessed at 15, 30, 60, 90 minutes and 2, 24 and 48 hours after treatment with study drug. Associated symptoms of nausea, photophobia, and phonophobia were assessed as secondary endpoints. The proportion of patients who had no headache at 2 hours (120 minutes) was also assessed. The percentage of patients achieving headache relief 2 hours after treatment was significantly greater in the Onzetra Xsail 22 mg group compared to those who received placebo (68% vs. 45%). For patients with migraine associated nausea, photophobia, and phonophobia at baseline, there was a lower incidence of these symptoms at 2 hours following administration of Onzetra Xsail compared with placebo.

Mechanism of Action

Onzetra Xsail is a nasal powder formulation of sumatriptan, a serotonin 5-HT1B/1D receptor agonist. Sumatriptan binds with high affinity to human cloned 5-HT1B/1D receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine headache through agonist effects at the 5-HT1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of proinflammatory neuropeptide release.