FDA approves nasal spray for migraines that may relieve symptoms within 30 minutes

The Food and Drug Administration has approved a nasal spray aimed at fast treatment for migraines, pharmaceutical company Pfizer said Friday. 

Zavegepant, sold under the brand name Zavzpret, was approved Thursday to treat migraines with and without aura in adults. The drug was more effective than a placebo at treating symptoms within 30 minutes and up to 48 hours later.  

“It’s an exciting addition to our toolbox that keeps getting bigger,” said Dr. Merle Diamond, a National Headache Foundation board member and managing director of the Diamond Headache Clinic at Saint Joseph Hospital in Chicago, who was not involved in the drug's development.

A migraine is defined as at least five headache attacks lasting four to 72 hours, according to the National Headache Foundation. Episodic migraines are more common than chronic migraines, health experts say, and are characterized by having two to eight migraines per month rather than 15 days a month.

“The FDA approval of Zavzpret marks a significant breakthrough for people with migraine who need freedom from pain and prefer alternative options to oral medications,” Angela Hwang, Pfizer's chief commercial officer, said in a statement.

Migraine nasal spray: ‘Very quick’ relief

Researchers found a 10mg dose of zavegepant was more effective than a placebo to relieve pain and other migraine symptoms after two hours, according clinical trial data published in February in The Lancet Neurology.

The findings also showed the nasal spray relieved migraine pain within 15 to 30 minutes after administration and lasted up to 48 hours in many patients.

“Fifteen minutes is very quick, even for other nasal sprays,” said Dr. Kate Mullin, primary investigator on the zavegepant trial and associate medical director the New England Institute for Neurology & Headache in Stamford, Connecticut.

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Among the 1,405 people who participated in the trial between October 2020 and August 2021, about 24% of those who took the drug said they experienced pain freedom two hours after treatment compared to 15% of people in the placebo group.

It’s not unusual for migraine trials to show high placebo rates, said Dr. Frederick Godley III, an otolaryngologist and president of the Association of Migraine Disorders.

“The crazy thing about migraines is that it comes and goes, and it has a big placebo effect,” he said. But the Pfizer study still shows that with zavegepant, “you’re just doubling the chances that you’re going to get rid of your headache.”

The most common side effect was a bad taste after administering the nasal spray, with about 21% of participants reporting odd or distorted tastes. Some people experienced hypersensitivity, including face swelling and hives, according to a Pfizer statement.

How to treat a migraine: Other options

Zavegepant, a gepant medication, is the first of its class of medications to come in nasal spray form.

Gepants work by blocking calcitonin gene-related peptide receptors, which experts say causes intense inflammation and is associated with migraine pain.

Zolmitriptan, is another nasal spray that treats the symptoms of migraine headaches, but it's a triptan medication. Triptans work by reducing inflammation and constricting blood vessels to stop a migraine. Due to this mechanism, health experts say triptans might not be safe for people with cardiovascular disease or high blood pressure.

Although there are oral gepant medications on the market, Godley said it’s important to have alternatives.

“Migraine is associated with nausea and vomiting sometimes so medicines taken orally don’t get absorbed because you get sick to your stomach and get rid of them,” Godley said.

Other drugs in the class are pills, which provide relief within two hours, but not 30 minutes. 

What to know about migraine symptoms

Migraines can cause severe throbbing pain or a pulsing sensation usually on one side of the head and are often accompanied by nausea, vomiting, or sensitivity to light and sound.

A migraine occurs when excited brain cells trigger a nerve to release chemicals that irritate blood vessels and cause them to swell on the surface of the brain, the foundation said.

Migraines most commonly occur in women ages 25 to 55, health experts say; fluctuations in estrogen before or during menstrual periods, pregnancy or menopause may trigger headaches.

A migraine attack also can be triggered by a change in sleep-wake cycle, missing or delaying a meal, medications, bright lights, excessive noise, stress or underlying depression, according to the headache foundation.

Some people experience migraines with aura, visual or sensory symptoms like flickering lights or feeling numbness or difficulty putting words together.

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