Pfizer’s migraine push builds with Zavzpret nod

Pfizer has a second FDA approval for a migraine therapy stemming from its $11.6 billion Biohaven takeover, getting the go-ahead for intranasal therapy Zavzpret to sit alongside its fast-growing oral therapy Nurtec ODT.

Zavzpret (zavegepant) is the first drug in the CGRP inhibitor class to be approved in a nasal spray formulation, designed to be a rapidly-acting therapy that can provide pain relief in as little as 15 minutes. It could also be an important option for people whose migraines tend to be accompanied by nausea – which can make taking tablets difficult.

Sales of Nurtec ODT (rimegepant) – approved as an oral therapy for migraine prevention and acute treatment – reached $194 million in sales in the fourth quarter of 2022.

It competes with other FDA-approved oral CGRPs, notably AbbVie’s prevention therapy Qulipta (atogepant) and Ubrelvy (ubrogepant) for acute treatment, which made $197 million and $52 million respectively in the three-month period.

Zavzpret gives Pfizer another string to its migraine bow, and one which analysts at Jefferies have suggested could help Pfizer’s CGRP franchise reach a lofty $4 billion in annual sales by the end of the decade. Pfizer said it plans to launch the new product in July.

Phase 3 testing of Zavzpret in a pair of pivotal trials showed that the drug was significantly better than placebo on the co-primary endpoints of pain freedom and freedom from most bothersome symptom two hours after dosing.

In one of the studies – published in the journal The Lancet Neurology – around a quarter (24%) or people who took a single intranasal 10 mg dose of Zavzpret were pain-free two hours later, compared to 15% of the placebo group.

That compares pretty well with the oral CGRPs – around 20% of Nurtec ODT patients were pain-free at two hours in its phase 3 trials – but some commentators have questioned whether the intranasal product is sufficiently differentiated from oral therapies to carve out a niche.

“Among my migraine patients, one of the most important attributes of an acute treatment option is how quickly it works,” commented Kathleen Mullin of the New England Institute for Neurology & Headache.

“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,” she added.