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FDA Gives Green Light to Sumatriptin Nasal Powder for Migraine
The FDA has approved Onzetra Xsail (sumatriptan nasal powder, Avanir Pharmaceuticals), formerly known as AVP-825, for the acute treatment of migraine with or without aura in adults. The product is an intranasal medication delivery system consisting of a low dose (22 mg) of sumatriptan powder that is delivered using the Xsail breath-powered delivery device. Onzetra Xsail is a fast-acting dry powder formulation of sumatriptan, the most commonly prescribed migraine medication.
The approval of Onzetra Xsail is based on data from phase II and phase III trials, on safety data from more than 300 patients, and on reference data from the clinical use of sumatriptan during the past 20 years. In the pivotal TARGET trial, 230 migraine patients were randomly assigned to self-administer either Onzetra or placebo using the Xsail breath-powered delivery device when they had moderate to severe migraine pain. Pain scores were assessed at various time points after administration. Pain was evaluated using a four-point scale, with headache relief defined as a reduction from moderate (grade 2) or severe (grade 3) pain to mild (grade 1) or complete relief (grade 0).
The study results demonstrated that a significantly greater proportion of Onzetra Xsail-treated patients reported headache relief at 30 minutes compared with those using the placebo device (42% vs. 27%, respectively; P = 0.03) and at every time point up to two hours post-dose (68% vs. 45%; P = 0.002). In pooled studies, the treatment was well tolerated, with a low incidence of adverse events (AEs). The most common AEs included product taste (20%), nasal discomfort (11%), rhinorrhea (5%) and rhinitis (2%); local AEs were transient and almost exclusively mild to moderate in severity.
Sumatriptan is contraindicated for certain patients, including those with a history of coronary artery disease or coronary vasospasm.
According to the Centers for Disease Control and Prevention, more than 37 million Americans experience migraine headaches. The triptan class of medications is generally considered the standard of care, with more than 14 million prescriptions written annually. Sumatriptan is the most commonly prescribed migraine drug in the U.S. In a published survey of 688 migraine patients, 71% were not fully satisfied with their current migraine treatment.
Source: Avanir Pharmaceuticals; January 28, 2016.