FDA Approves Nasal Spray That Relieves Migraine in Minutes
/By Pat Anson, PNN Editor
Pfizer will soon launch a fast-acting nasal spray that can relieve migraine pain in as little as 15 minutes for some patients. The company has received FDA approval for Zavzpret (zavegepant), the first calcitonin gene-related peptide (CGRP) inhibitor formulated into a nasal spray for the acute treatment of migraine in adults with or without aura.
“When a migraine hits, it has a significant negative impact on a person’s daily life,” Kathleen Mullin, MD, Associate Medical Director at New England Institute for Neurology & Headache, said in a Pfizer press release. “Among my migraine patients, one of the most important attributes of an acute treatment option is how quickly it works. 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, so they can get back to normal function quickly.”
That’s the good news. The bad news is how expensive the nasal spray is likely to be when it becomes available in July 2023. According to a Pfizer spokesperson, Zavzpret “is expected to be comparable in price to other FDA approved CGRP migraine medicines.”
CGRP is a protein that binds to nerve receptors in the brain and dilates blood vessels, causing migraine pain. Since their introduction in 2018, CGRP inhibitors have become the biggest innovation in migraine treatment in decades, although their cost is prohibitive for many patients.
Eight doses of Nurtec, a CGRP-inhibiting tablet taken daily to prevent and treat migraine, can cost over $1,000, while the listed price for Emgality, a CGRP-inhibiting solution, is $679 for a self-injectable syringe used once a month for migraine prevention. Prices will vary for patients, depending on their insurance and whether they qualify for a patient assistance program.
In a Phase 3 study involving over 1,400 patients, recently published in The Lancet Neurology, a single 10mg dose of Zavzpret relieved migraine pain in as little as 15 – 30 minutes, and provided sustained relief for as long as 48 hours.
An important caveat is that the nasal spray did not help everyone. Only 22.5% of patients were pain free after two hours, compared to 15.5% who were given a placebo.
The 7% difference may sound like marginal improvement in a minority of patients, but in the parlance of clinical trials it’s considered “statistically significant” improvement.
Zavzpret was well tolerated by most patients. The most common adverse reactions after ingesting the spray were taste disorders (dysgeusia and ageusia), nausea, nasal discomfort and vomiting.
PFIZER IMAGE
“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,” said Angela Hwang, Chief Commercial Officer and President of Pfizer’s Global Biopharmaceuticals Business.
Migraine affects about 39 million people in the United States, according to the American Migraine Foundation. In addition to headache pain, migraine can cause nausea, blurriness or visual disturbances, and sensitivity to light and sound. Women are three times more likely to suffer from migraines than men.
