FDA Approves Nasal Spray Migraine Therapy

(geralt, Pixabay)

29 January 2016. The Food and Drug Administration approved a treatment for migraine headaches delivered as a powder sprayed into the nose. The therapy, marketed as Onzetra by Avanir Pharmaceuticals, is a formulation of sumatriptan, an approved oral drug for treating migraine symptoms.

Migraine is a neurological syndrome causing severe headaches along with nausea, vomiting, and extreme sensitivity to light and sound. In some cases, migraines are preceded by warning episodes called aura including flashes of light, blind spots, or tingling in arms and legs. Migraine Foundation says the syndrome is one of the top 20 disabling disorders and estimates some 36 million people suffer migraines in the U.S., including 14 million who experience migraines nearly every day or more often.

Sumatriptan, approved by FDA in 1992, stimulates serotonin receptors in the brain that narrow blood vessels and stop pain signals sent to the brain. Serotonin is a neurotransmitter chemical generated in the brain, regulating signals between neurons that helps maintain mood balance. Decreased levels of serotonin are associated with depression.

Onzetra is administered with a nasal delivery system, where sumatriptan is absorbed faster into the brain than pills, which must be absorbed from the stomach. The delivery device, which the company calls Xsail, carries a low, measured dose of the medication in dry powder form, with a piece that fits in the patient’s nostril and a separate piece that goes in the mouth. The patient exhales into the device, which sends the dose of sumatriptan into the nose and into the nasal passages, deeper than can be delivered with a normal nasal spray, for transfer into the blood stream near the brain.

Avanir conducted a number of clinical trials, including intermediate and late-stage studies with more than 300 participants. The results, say the company, show more individuals with migraines taking Onzetra report headache relief within 30 minutes, and at other points up to 2 hours after taking the drug, than participants receiving a placebo. The trials also report a low incidence of adverse effects from the treatment.

Approval by FDA, however, was delayed three months due to questions from the agency about errors in using the Xsail device, which required Avanir to conduct an additional human factors study to address those concerns. FDA’s approval covers treatment for migraines after they occur, either with or with aura, and not for prevention of migraines. In addition, the drug is approved only after a clear diagnosis of migraine is made. Approval does not cover use of the drug for cluster headaches, a cyclical attack of severe headache pain.

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