FDA Approves New Inhaler for Migraine

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a new type of inhaler for the treatment of acute migraine in adult patients with or without aura.

Onzetra Xsail delivers a low dose of a dry powder formulation of sumatriptan, the most commonly prescribed medication for migraine.

"Onzetra Xsail provides a new and much needed treatment option for what can be a debilitating condition for millions of people," said Roger Cady, MD, 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."

The inhaler is activated when a 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. The 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 reduces gastrointestinal absorption.

Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. About half of people living with migraine are undiagnosed.

“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, MD, professor of neurology at the Geisel School of Medicine at Dartmouth.

The FDA approved Onzetra after clinical trials showed the inhaler provided headache relief to about 40% of users within 30 minutes. About two-thirds of users reported pain relief after two hours. Side effects include abnormal product taste, nasal discomfort, rhinorrhea and rhinitis.