The Food and Drug Administration on Friday approved a new migraine medicine from Pfizer, bolstering the roughly $12 billion bet the company made on the drug’s developer, Biohaven Pharmaceuticals, last year.
The FDA has cleared the nasal spray, formerly known as zavegepant and to be sold as Zavzpret, as an acute treatment for adults with migraines. Pfizer expects the drug to be available in pharmacies in July.
In an email to BioPharma Dive, a Pfizer spokesperson said the drug’s price will be available at launch and “is expected to be comparable” to other, similar types of marketed migraine drugs. “We are actively engaged with all payers and [pharmacy benefit managers] to ensure access to zavegepant,” the spokesperson added.
Zavzpret was a key part of Pfizer’s May 2022 acquisition of Biohaven, a deal that represented a gamble on the future growth of the biotechnology company’s portfolio of migraine medicines. The deal handed Pfizer rights to Nurtec ODT, a pill for migraine prevention and treatment, as well as Zavzpret and a group of preclinical treatments.
Nurtec alone added $211 million to Pfizer’s sales following the acquisition last year, and brought in $463 million for Biohaven in 2021. Pfizer believes sales of that drug and Zavzpret will grow substantially, as well as offset some of the steep declines expected for its COVID-19 treatments as well as patent expirations for some of its other medicines. In January, the company predicted the two medicines will achieve more than $6 billion in combined peak yearly sales.
To reach that goal, Zavzpret will have to succeed commercially as well. Like Nurtec, it inhibits CGRP, a protein that’s released during migraine attacks. But as a nasal spray, it could avoid some of the gastrointestinal side effects seen in clinical trials of Nurtec and other oral migraine medicines from Eli Lilly and AbbVie. It also works quickly. Study results published in the Lancet Neurology show benefits observed over placebo in as little as 15 minutes and pain relief lasting for one to two days.
“Among my migraine patients, one of the most important attributes of an acute treatment option is how quickly it works,” said Kathleen Mullin, the associate medical director at the New England Institute for Neurology & Headache, in Pfizer’s statement. “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.”
Altered taste and nasal discomfort were among the most common side effects reported in clinical testing. The drug is contraindicated in patients with hypersensitivity to the drug or any of its components.
Biohaven originally licensed the medicine from Bristol Myers Squibb.