07 Mar New Medication Delivery System for Migraine Wins Approval
The U.S. Food and Drug Administration recently approved Onzetra Xsail (sumatriptan nasal powder) for the treatment of migraine, with or without aura, in adults. The medication is part of an intranasal delivery system that includes a low-dose (22mg) of sumatriptan powder, which is delivered via a breath-powered device.
The news of the approval for the system was greeted cautiously by some headache experts, who note that sumatriptan, the most commonly prescribed migraine medication, is already available in a variety of administrative forms, including nasal spray and injection. Other headache specialists were more enthusiastic, including Roger K. Cady, MD, director of the Headache Care Center in Springfield, MO, and Associate Executive Chairman of the National Headache Foundation. He called the device “a new and much-needed treatment option” and noted that the device allows the medication to be deposited deep into the nose, where it can be absorbed quickly.
To use the Xsail system, patients exhale into the device, and the nasal cavity is automatically sealed off. As the medication is delivered, the air flows around to the opposite side of the nose and exits through the other nostril. The soft palate closes, which helps prevent swallowing and reduces gastrointestinal absorption.
During trials, nearly 42% of 230 participants who used the device reported headache relief at 30 minutes compared to nearly 27% who used a placebo. Additionally, more than 67% of those who used the device reported greater pain relief up to 2 hours post-dose compared to approximately 42 percent using a placebo.
Treatment was well-tolerated with a low incidence of adverse effects; however, sumatriptan is contraindicated in some patients, including those with a history of coronary artery disease.
The system is manufactured by Avanir Pharmaceuticals, Inc., based in Aliso Viejo, CA, and is expected to be available during the coming months.