Now, five months after completing the purchase, Pfizer has taken a nasal spray with the same mechanism of action across the FDA finish line. On Friday, the regulator signed off on Zavzpret (zavegepant) for the treatment of migraine headaches in adults.
Zavzpret and Nurtec are from the calcitonin gene-related peptide (CGRP) receptor antagonist class of medicines. After a dual approvals in 2020 and 2021, Nurtec became the first medicine to treat and prevent migraines. Now Zavzpret becomes the first CGRP in nasal spray form. Pfizer said it expects to launch the drug in July.
As opposed to older triptan medications—which constrict blood vessels to halt migraine pain—so-called "gepant" drugs Zavzpret and Nurtec are designed to get to the source of migraine pain by blocking calcitonin gene-related peptide receptors, which cause inflammation.
The approval of Zavzpret is a “significant breakthrough” for patients who “prefer alternative options to oral medications,” Angela Hwang, Pfizer’s chief commercial officer and president of its global biopharmaceuticals business, said in a release.
Because nausea and vomiting can accompany migraine headaches in some patients, the effectiveness of oral treatments can be limited.
In two phase 3 studies, nasal spray zavegepant was more effective than placebo at 30 minutes and up to 48 hours. After two hours, 24% of participants were free of pain versus 15% in the placebo group. The primary side effect, reported by 21% of those on zavegepant, was an altered sensation of taste.
Zavzpret enters a competitive market which includes three injected treatments which were approved in 2018—Eli Lilly’s Emgality, Amgen’s Aimovig, Teva’s Ajovy—and a newer oral drug AbbVie’s Qulipta, which was endorsed 18 months ago.
Emgality had sales of $651 million in 2022, which was a 13% increase from 2021. Aimovig’s sales came in at $414 million last year for an increase of 31% over the previous year. Ajovy had $75 million in revenue, up 41% from 2021, while Qulipta generated $52 million in its first full year on the market.
AbbVie’s CGRP pill Ubrelvy was approved in 2019 to treat migraine. It generated $680 million in sales last year for an increase of 23% on 2021. Lilly’s oral CGRP Reyvow was endorsed the same year. The company does not yet list Reyvow’s sales figures.
Impel Pharmaceuticals' Trudhesa, with a different mechanism of action, is a nasal spray that was approved in 2021 and is off to a promising launch.
Pfizer's deal to obtain Biohaven was second largest in the biopharma M&A arena in 2022. Pfizer already had made a licensing deal with Biohaven to commercialize Nurtec and zavegepant before the companies talked of a full acquisition.