FDA Approves Fast-Acting Nasal Spray for Migraines, Pfizer Says

FDA Approves Fast-Acting Nasal Spray for Migraines, Pfizer Says

March 10, 2023 — The FDA has approved a nasal spray that is expected to provide fast relief from migraines, the pharmaceutical company Pfizer said Friday.

The drug zavegepant will be sold under the brand name Zavzpret and should be available in pharmacies by July 2023, the company said in a news release. The cost of the drug has not been revealed yet.

Clinical trials published in The Lancet Neurology showed the nasal spray provided migraine relief within 15-30 minutes of use, with the relief lasting up to 48 hours in many patients, Pfizer said. About 1,400 people participated in the trials from October 2020 to August 2021. 

“Among my migraine patients, one of the most important attributes of an acute treatment option is how quickly it works,” Kathleen Mullin, MD, associate medical director at New England Institute for Neurology & Headache, said in the Pfizer release.

“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.”

Pfizer says Zavzpret is the first product of its kind. It works by blocking the peptide receptors that cause inflammation that often comes with migraine.

Pfizer said the drug was approved to treat acute migraine with or without aura – meaning a severe headache accompanied by uncomfortable symptoms such as dizziness, a ringing in the ears, zigzag lines in vision, or sensitivity to light.

The American Migraine Foundation says 39 million Americans and 1 billion people worldwide live with migraine.

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