FDA Approves Zavegepant Nasal Spray for Acute Treatment of Migraine in Adults

The FDA has approved zavegepant (Zavzpret; Pfizer) as the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine in adults with without aura, according to a press release. The FDA approved zavegepant because it was found effective, tolerable, and safe in a pivotal phase 3 study published in The Lancet Neurology.

“The FDA approval of zavegepant marks a significant breakthrough for people with migraine who need freedom from pain and prefer alternative options to oral medications,” said Angela Hwang, chief commercial officer, president, Global Biopharmaceuticals Business, Pfizer, in the press release.

Approximately 40 million US adults suffer from migraine, and it is the number 2 cause of disability around the world, according to the World Health Organization (WHO). Migraine can be debilitating, with symptoms of moderate to severe pulsating headache that result in nausea, vomiting, or sound and light sensitivity (phonophobia and photophobia) that can last up to 3 days.

“When a migraine hits, it has a significant negative impact on a person’s daily life,” said Kathleen Mullin, MD, associate medical director at the New England Institute for Neurology and Headache, in a press release. “Among my migraine patients, one of the most important attributes of an acute treatment option is how quickly it works.”

Zavegepant was found statistically superior to placebo in 2 pivotal, randomized, double-blind, placebo-controlled studies comparing zavegepant with placebo for the acute treatment of migraine. The small molecule CGRP receptor antagonist nasal spray met co-primary endpoints of reduced moderate to severe headache pain to no pain (pain freedom), and a self-identified reduction in patients’ most bothersome symptoms 2 hours after treatment (freedom from most bothersome symptom at 2 hours post-dose).

Zavegepant was also found more effective than placebo across 76% (13 of 17) prespecified secondary outcome measures. Zavegepant surpassed placebo in:

• Early time point endpoints (relieve pain within 15 to 30 minutes, return to normal function in 30 minutes).
• Return to normal function after 2 hours.
• Durable efficacy endpoints (sustained pain freedom, sustained pain relief from 2 to 48 hours).

The nasal spray was also well-tolerated in clinical trials. The most common adverse events (AEs) include risk of taste disorders including dysgeusia and ageusia, nausea, nasal discomfort, and vomiting (reported in 2% or more of patients). The medication is contradicted in patients who are hypersensitive to zavegepant or related components. AEs may include facial swelling and urticaria.

Zavegepant is indicated for the acute treatment of migraine and cannot prevent them. It is expected to be available in US pharmacies starting in July 2023.

“As a nasal spray with rapid drug absorption, zavegepant 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,” Mullin said in the release.

Reference

Pfizer. Pfizer’s ZAVZPRET™ (zavegepant) Migraine Nasal Spray Receives FDA Approval. News Release. March 10, 2023. Accessed March 10, 2023. https://www.pfizer.com/news/press-release/press-release-detail/pfizers-zavzprettm-zavegepant-migraine-nasal-spray