Migraine nasal spray from Pfizer receives FDA approval for expected summer launch
People who suffer from migraines will soon have access to pain relief in the form of a nasal spray.
The US Food and Drug Administration (FDA) has approved the first calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray intended to treat migraine in adults.
Pfizer manufactures the drug, called Zavzpret. It works by blocking CGRP, a protein released around the brain that triggers migraines.
News of the FDA’s 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 marks a significant breakthrough for people with migraine who need pain relief and prefer alternative options to oral medications,”[ads1]; said Angela Hwang, president of Pifizer’s global biopharmaceutical business in New York Cityin the press release.
“Zavzpret underscores Pfizer’s commitment to providing an additional treatment option to help people with migraine get relief and get back to everyday life.”
Pfizer touts rapid pain relief as the biggest benefit of Zavzpret.
In clinical trials, the nasal spray was found to begin reducing pain in as quickly as 15 minutes — and to enable patients to resume normal activities as quickly as 30 minutes later, the press release claimed.
The medicine is also said to eliminate moderate to severe headache pain 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 that people with migraine will have access to Zavzpret via a doctor’s prescription from July 2023.
“Among my migraine patients, one of the most important attributes of an acute treatment option is how quickly it works,” said Kathleen Mullin, MD, assistant medical director at the New England Institute for Neurology & Headache in Stamford, Connecticutin Pfizer’s press release.
Migraines affect more than 17% of women and 5.6% of men in the United States
“As a nasal spray with rapid drug absorption, Zavzpret offers an alternative treatment option for people who need pain relief or cannot take oral medications due to nausea or vomiting, allowing them to quickly return to normal function,” the doctor continued.
Dr. Randa Jaafar, a New York-based pain management physician, told Fox News Digital that she believes Zavzpret will be a great addition to the current medications used to treat acute migraines.
“We currently have other CGRP drugs, but they are administered either orally or by injection, which have limitations,” she said by email.
“The Limitation of Oral [medication] is that a migraine can be associated with nausea and vomiting, which makes it difficult to tolerate a pill. And injectables will not be beneficial for patients with needle phobias.”
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Some side effects were reported in 2% or more of study participants.
These included taste disturbances, nausea, nasal discomfort and vomiting, Pfizer noted in the press release.
Hypersensitive patients may experience skin rashes and facial swelling.
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The World Health Organization (WHO) includes migraine in its list of the 10 most debilitating medical illnesses.
In the United States, the condition affects more than 17% of women and 5.6% of men, according to the Jama Network.