Avanir announced that the Food and Drug Administration (FDA) has approved Onzetra (sumatriptan nasal powder) Xsail for the treatment of migraine with or without aura in adults.
Onzetra Xsail consists of fast-acting, low-dose sumatriptan as a dry powder that is delivered via the Xsail Breath Powered Delivery Device. The breath powered delivery is activated by the patient’s breath to propel medication into the nasal cavity. The patient exhales into the device, which seals the nasal cavity, and this carries the medication from the device directly into one side of the nose.
The approval of Onzetra Xsail is supported by data from Phase 2 and 3 clinical trials, safety data from over 300 patients, and reference data from sumatriptan over the past 20 years. The TARGET trial (n=230) randomized patients with migraines to self-administer Onzetra Xsail or placebo when they experienced moderate to severe migraine pain. Study investigators assessed pain scores at various time points after administration.
The data showed a significantly greater proportion of Onzetra Xsail patients reported headache relief at 30 minutes (41.7% vs. 26.9%; P=0.03) and at every time point up to 2 hours post-dose vs. placebo patients (67.6% vs. 45.2%; P=0.002).
Onzetra Xsail will be supplied as a disposable nosepiece containing a capsule and a reusable device. Each capsule contains 11mg sumatriptan base and each kit contains 8 doses. It is anticipated to launch in the coming months.
For more information call (844) 669-3872 or visit Onzetra.com.