FDA approves new treatment for migraines

By Lisa Cantkier

Migraine syndrome affects over 12% of the population, including children. The U.S. Food and Drug Administration (FDA) has approved the medication ONZETRA Xsail, formerly “AVP-825” (sumatriptan nasal powder) with the use of the Xsail breath powered delivery device for the acute treatment of migraine with or without aura in adults. It is not indicated for the prevention of migraine attacks and it’s safety and effectiveness has not been determined for the treating cluster headaches.

Sumatriptan is in a class of medications called “selective serotonin receptor agonists.” It narrows the blood vessels in the head, stops pain signals from being sent to the brain, and blocks the release of certain natural substances that cause pain, nausea, and other symptoms of migraine. The medication is a low-dose powder, administered through the nose with a unique Xsail breath powered delivery device, providing another option for migraine sufferers.

The Xsail breath powered delivery device works in a new and different way, by using the patient’s breath to help deliver the medication into deep areas of the nasal cavity. After exhaling into the device, the patient’s exhaled breath takes the medication into the nose (nostril) through a nose piece. The medication is then carried beyond the nasal valve to specific sites. Then air flows to the opposite side of the nasal cavity and goes out through the other nostril.

ONZETRA Xsail was approved by the FDA for the acute treatment of migraine based on research involving 230 patients with migraine.  They were randomly assigned to self-administer the sumatriptan powder or a placebo using the Xsail breath powered delivery device when experiencing moderate to severe migraine pain. The results showed that a significantly greater number of patients who received the treatment proclaimed they had headache relief after 30 minutes and at every time point studied, up to 2 hours post-treatment, in comparison with patients who instead used the placebo device. Adverse reactions associated with the use of the medication were abnormal taste, nasal discomfort, rhinitis (inflammation of the nose or its mucous membrane) and rhinorrhea (excessive discharge of mucus from the nose).

“The design of the Xsail Breath Powered Delivery Device harnesses the patient’s own breath to seal off the nose from the throat and deliver a low dose of a trusted medication to the richly vascular passages deep in the nose.  It’s an alternate approach to treating migraines that is both unique and effective,” said Stephen Silberstein, MD, Neurologist at the Headache Center, Thomas Jefferson University Hospital in Philadelphia, PA, Past President of the American Headache Society and a Principal Investigator in the OptiNose clinical development program for ONZETRA Xsail.

For more information, click here.

Last Reviewed 03/01/16

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Lisa Cantkier, CHN is a certified holistic nutritionist and a health and wellness editor.

Statements and opinions expressed on this Web site are those of the authors and not necessarily those of the publishers or advertisers. The information provided on this Web site should not be construed as medical instruction. Consult appropriate health-care professionals before taking action based on this information.

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