The Food and Drug Administration has approved a Pfizer nasal spray for treatment of migraines that uses a different therapy from other nasal products on the market for severe headache pain, the company said on Friday.
The fast-acting treatment, which is called zavegepant and will be sold as Zavzpret, performed better than a placebo in relieving pain and patients’ most bothersome symptoms, according to clinical trial results published in the journal Lancet Neurology. Participants in the trial who took the medication were more likely to report returning to normal function 30 minutes to two hours after taking it.
The gains, though, were not significant for every patient. A study tracked the experience of 1,269 patients — half on the drug and half on a placebo — focusing on how they reported feeling two hours after using either substance. About 24 percent on the medication reported freedom from pain, compared to about 15 percent who took a placebo, according to the study.
Dr. Timothy A. Collins, chief of the headache division at Duke University Medical Center’s neurology department, said the product gave doctors a new option in a nasal spray format that patients with migraines tended to appreciate. He said the condition often comes with nausea, so swallowing a pill can be unpleasant. He also said the drug presented few side effects, like drowsiness, that had been reported with other products.
“We’ve been waiting for this medication to come out,” Dr. Collins said. “It’s a really helpful addition to migraine management.”
One additional upside of the medication is that it’s safe for patients who have had a heart attack or a stroke, he added.
Pfizer said the medication would be available in pharmacies in July, but did not disclose the estimated price of the new spray. The company estimated that nearly 40 million people in the United States suffered from migraines each year.
Calling the F.D.A.’s approval a “significant breakthrough,” Pfizer described the medication as the first and only nasal spray for migraines using a migraine inhibitor that attempts to block the release of proteins called calcitonin gene-related peptides, which studies have shown are present in greater volume during an attack and that can cause inflammation and pain. Some other nasal products use triptans, which are a class of drugs aimed at serotonin receptors but are generally not recommended for people with vascular diseases.
Dr. Rashmi Halker Singh, an associate professor of neurology at the Mayo Clinic who cares for patients with migraines, said the new medication built on a discovery about the role of calcitonin gene-related peptides that was decades in the making.
“And I think that discovery has been really groundbreaking in helping us to better understand what happens when someone is having a migraine attack,” she said.
While medications in the class exist in pill form, nasal sprays are absorbed more quickly, another benefit of Pfizer’s new treatment.
“Hopefully this will help us help more people,” Dr. Halker Singh said. “That’s the bottom line, right?”
The major study of the drug also measured the trial participants’ freedom from their most bothersome symptoms two hours after taking the medicine. Forty percent of those taking it reported an improvement. Among those on a placebo, the result was 31 percent.
Some side effects were reported by trial participants. About one-fifth of those who took the medication reported an altered sense of taste. Others experienced nasal discomfort and nausea.
The authors concluded that “additional trials are needed to establish the long-term safety and consistency of effect across attacks.”
