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Avanir Pharmaceuticals announces FDA approval of ONZETRA Xsail (AVP-825) for the acute treatment of migraine in adults

Avanir Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved ONZETRA™ Xsail™ (sumatriptan nasal powder), 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.

“While there are many acute migraine treatment options available, more than 70% of patients are not fully satisfied with their current migraine treatment. Given this high dissatisfaction, there remains an unmet need to provide patients with fast-acting, well tolerated therapies that deliver consistent relief,” said Stewart Tepper, M.D., professor of neurology at the Geisel School of Medicine at Dartmouth.

“ONZETRA Xsail provides a new and much needed treatment option for what can be a debilitating condition for millions of people,” said Roger K. Cady, M.D., director of the Headache Care Center and associate executive chairman of the National Headache Foundation. “The Xsail Breath Powered Delivery Device allows the medication to be deposited deep into the nose, an area that is rich with blood vessels. By delivering the medication here, ONZETRA Xsail provides targeted and efficient delivery with the potential for fast, consistent relief, while also limiting the amount of medicine that goes down the back of the throat.”

“We are excited about this major milestone for Avanir as the approval of ONZETRA Xsail represents our second approved product. We expect to make ONZETRA Xsail available to patients in the coming months,” said Rohan Palekar, president and CEO of Avanir. “We continue to be focused on building a leading CNS biopharmaceutical company and the addition of ONZETRA Xsail to our product portfolio takes us closer to achieving that goal.”

About the ONZETRA Xsail Clinical Trial Program

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%, P=0.03) and at every time point up to two hours post-dose compared with those using the placebo device (67.6% vs. 45.2%, P=0.002). 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.

About ONZETRA Xsail

ONZETRA Xsail is an intranasal medication delivery system consisting of low-dose (22mg) sumatriptan powder, the most commonly prescribed migraine medication. The medication is delivered intranasally utilizing the novel Xsail Breath Powered Delivery Device. It is a fast-acting dry-powder intranasal form of sumatriptan for the acute treatment of migraine. Sumatriptan is the most widely used prescription migraine medication and has been used safely for over 20 years. Sumatriptan is contraindicated for certain patients, including those with a history of coronary artery disease (CAD) or coronary vasospasm.

The breath powered delivery technology is activated by a user’s breath to propel medication deep into the nasal cavity where absorption is more efficient and consistent. The user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity. Through a sealing nosepiece placed into the nostril, the exhaled breath carries medication from the device directly into one side of the nose. Narrow nasal passages are gently expanded and medication is dispersed deep into the nasal cavity reaching areas where it can be rapidly absorbed. As the medication is delivered, the air flows around to the opposite side of the nasal cavity and exits through the other nostril. Closure of the soft palate helps prevent swallowing and reduce GI absorption.