Nasal spray that relieves migraines in minutes approved by FDA

Pfizer is planning to launch a fast-acting nasal spray that can relieve pain from migraines in as little as 15 minutes for some patients. Zavzpret (zavegepant) has been approved by the FDA as the first calcitonin gene-related peptide (CGRP) inhibitor formulated as a nasal spray to treat acute migraines in adults with or without aura.

This approval marks a positive step in the treatment of migraines, however it is likely to be highly expensive once it hits the market. A Pfizer spokesperson said Zavzpret “is expected to be comparable in price to other FDA approved CGRP migraine medications.” As an example, eight doses of Nurtec, another CGRP-inhibiting tablet taken daily to prevent and treat migraines, can cost over $1,000.

The approval follows data from a phase 3 study including over 1,400 patients given a single 10mg dose of the drug. The trial showed that the drug relieved migraine pain in 15-30 minutes, providing relief for up to 48 hours. However, only 22.5% patients were pain free after two hours, compared to 15.5% from the placebo group.

Kathleen Mullin, MD, associate medical director at New England Institute for Neurology and Headache, commented: “When a migraine hits, it has a significant negative impact on a person’s daily life. 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.”

Angela Hwang, chief commercial officer and president of Pfizer’s Global Biopharmaceuticals Business, added: “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.”

Betsy Goodfellow