FDA Approves a New Nasal Spray to Treat Migraines

On Mar. 10, the U.S. Food and Drug Administration (FDA) approved a new treatment for migraines given as a nasal spray, according to the drug’s maker, Pfizer.

Zavegepant (brand name: Zavzpret), is the first of a class of migraine treatments known as calcitonin gene-related peptide receptor (CGRP) antagonists to be approved as a nasal spray. Until now, these types of drugs have only been available in oral and injectable forms. In a release announcing the approval, Pfizer says zavegepant will be available in pharmacies in July.

In studies previously released by Pfizer and reviewed by the FDA, zavegepant reduced moderate-to-severe headache pain two hours after people used the spray compared to those who squirted a placebo up their nose. Among those receiving the spray, 24% reported pain relief after two hours, compared to 15% of those getting placebo. For some people getting the drug, relief began as soon as 15 minutes after they took the medication.

“With CGRP medications, scientists for the first time looked at the pathophysiology of migraine, or what was causing migraine, in order to understand how to modify and alter that process,” says Dr. Kathleen Mullin, associate medical director at New England Institute for Neurology and Headache, and an investigator on one of the zavegepant trials. Experts believe that blocking the calcitonin gene-related peptide receptors in the brain reduces inflammation that is linked to migraine pain.

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Older classes of migraine treatments—such as triptans—work by constricting blood vessels, which is one way to reduce pain in the brain. But such constriction is dangerous for people with heart-related conditions, so that population of headache sufferers have not been able to take the drugs or had to use suboptimal doses to relieve their migraine pain.

While CGRP antagonists expanded the group of migraine patients who could find relief with medication, they still left out many patients who couldn’t take pills once their headaches began. Many people experience nausea and vomiting during their migraines and can’t take anything by mouth. In addition, says Mullin, migraines cause a slowing of movement in the digestive tract, so any oral medications aren’t absorbed as quickly and efficiently as they normally would be. A nasal spray acts more quickly and avoids these deterrents.

CGRP antagonist medications are used to both prevent and treat migraines, but zavegepant is approved only to treat acute migraine pain once an episode starts. For people who experience four or more migraines a month, doctors can prescribe an injectable CGRP either once a month or every three months. For every migraine patient, however, Mullin says that treatment is important, since “we know that the more headaches people get, the more headaches they will continue to get. Even if you get one headache every three months, your doctor should be prescribing an acute medication to stop that headache.”