Migraine nasal spray from Pfizer snags FDA approval for expected summer launch
People who suffer from migraines will soon have them access to pain relief in the form of a nasal spray.
The U.S. Food and Drug Administration (FDA) has approved the first calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray intended to treat migraines in adults.
Pfizer produces the drug, called Zavzpret. It works by blocking CGRPs, a protein released around the brain that triggers migraines.
News of the FDA approval came after two randomized, double-blind, placebo-controlled trials, Pfizer noted in a press release announcing the approval.
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“The FDA approval of Zavzpret represents a major breakthrough for people with migraines who want to be pain free and prefer alternative oral medication options,” said Angela Hwang, president of Pifizer’s global biopharmaceutical division in the city of New Yorkin the press release.
“Zavzpret underscores Pfizer’s commitment to providing a complementary treatment option to help people with migraines gain relief and return to their daily lives.”
Pfizer touts rapid pain relief as Zavzpret’s biggest benefit.
In clinical trials, the nasal spray was found to reduce pain within as little as 15 minutes — and allow patients to resume normal activities within 30 minutes later, the press release claimed.
The drug would also eliminate moderate to severe headache within two hours, with effects lasting up to 48 hours.
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Zavzpret is intended to treat acute migraine symptoms; it doesn’t stop them.
Pfizer expects migraine patients to have prescription access to Zavzpret from July 2023.
“In my migraine patients, one of the most important features of an acute treatment option is how quickly it works,” says Kathleen Mullin, MD, associate medical director at the New England Institute for Neurology & Headache in Stamford, Connin Pfizer’s press release.
Migraines affect more than 17% of women and 5.6% of men in the US
“As a rapid drug absorption nasal spray, Zavzpret provides an alternative treatment option for people who need pain relief or are unable to take oral medications due to nausea or vomiting, helping them quickly return to normal function,” the doctor continued.
Dr. Randa Jaafar, a New York-based pain management physician, told Fox News Digital she believes Zavzpret will be a great addition to current medications used to treat acute migraines.
“We currently have other CGRP drugs, but they are given orally or by injection, which have limitations,” she said via email.
“The limitation with oral [medication] is that migraines can be accompanied by nausea and vomiting, making it difficult to tolerate a pill. And injectables will not benefit patients with needle phobias.”
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Some side effects were reported in 2% or more of study participants.
These include taste disturbances, nausea, nasal discomfort and vomiting, Pfizer noted in the press release.
Hypersensitive patients may experience skin rashes and swelling of the face.
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The World Health Organization (WHO) includes migraine in the list of the 10 most common debilitating medical conditions.
In the US, the condition affects more than 17% of women and 5.6% of men, according to the Jama Network.