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.

Side Effects

Adverse effects associated with the use of Onzetra Xsail may include, but are not limited to, the following:

Abnormal taste

Nasal discomfort

Rhinorrhea

Rhinitis

Dosing/Administration

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 two hours.

Clinical Trial 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 end points. The proportion of patients who had no headache at two hours (120 minutes) was also assessed. The percentage of patients achieving headache relief two hours after treatment was significantly greater in the Onzetra Xsail 22-mg group compared to those who received placebo (68 percent vs. 45 percent). For patients with migraine-associated nausea, photophobia and phonophobia at baseline, there was a lower incidence of these symptoms at two hours following administration of Onzetra Xsail compared with placebo.