FDA approves Onzetra Xsail (sumatriptan nasal powder) for migraine- Avanir Pharmaceuticals

The FDA has approved Onzetra Xsail (sumatriptan nasal powder), from Avanir Pharmaceuticals, formerly known as AVP 825, for the acute treatment of migraine with or without aura in adults. Onzetra Xsail is an intranasal medication delivery system consisting of a low-dose (22mg) of sumatriptan powder that is delivered utilizing the novel 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, safety data from more than 300 patients, and reference data from the extensive clinical use of sumatriptan over the past 20 years. In the pivotal TARGET trial, 230 migraine sufferers were randomized 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 then 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). Study results demonstrated that a significantly greater proportion of Onzetra Xsail patients reported headache relief at 30 minutes (41.7% vs. 26.9%) and at every time point up to two hours post-dose compared with those using the placebo device (67.6% vs. 45.2%). The treatment was well tolerated with a low incidence of adverse events (AEs). In addition, in pooled studies, the treatment was well tolerated with a low incidence of AEs, with the most common AEs being abnormal product taste (20%), nasal discomfort (11%), rhinorrhea (5%) and rhinitis (2%); local AEs were transient and almost exclusively mild to moderate in severity.

Comment: The therapy will have generic sumapriptan to compete against. While 42% of patients treated with Onzetra Xsail in the TARGET trial felt pain relief within 30 minutes of dosing, it is estimated that about 30% of patients treated with sumitriptan nasal spray experienced pain relief within 30 minutes in prior clinical trials. The difference may not be enough to differentiate the Onzetra Xsail product.