Sumatriptan is a medication used for the treatment of migraine headaches.It is a synthetic drug belonging to the triptan class. Structurally, it is an analog of the naturally occurring neuro-active alkaloidsdimethyltryptamine (DMT), bufotenine, and 5-methoxy-dimethyltryptamine, with an N-methyl sulfonamidomethyl- group at position C-5 on theindole ring.
Sumatriptan is produced and marketed by various drug manufacturers with many different trade names such as Imitrex, Imigran, and Treximetas a combination product with naproxen.Avanir Pharmaceuticals, Inc. today 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.”