FDA accepts review of Biohaven’s NDA for zavegepant nasal spray

Zavegepant nasal spray is claimed to be the only small molecule calcitonin gene-related peptide (CGRP) receptor antagonist in an intranasal formulation for the acute treatment of migraine in adults.

The completion of the FDA review of the NDA is set for Q1 of 2023.

Biohaven CEO and chairman Vlad Coric said: “People with migraine want an acute treatment that provides fast, lasting relief from the debilitating symptoms of this disease.

“If approved, zavegepant would provide a new treatment option for patients who need ultra-rapid relief, in as early as 15 minutes, and for those that experience nausea or vomiting and need a non-oral treatment option.

“We have generated robust data from two intranasal zavegepant pivotal trials that were submitted with our NDA and look forward to bringing this new treatment option to people suffering from migraine.”

The NDA for zavegepant was based on two double-blind, placebo-controlled studies.

These studies established the efficacy, tolerability and safety profile of zavegepant for the acute treatment of migraine.

In the studies, zavegepant was found to be statistically superior to placebo on the coprimary regulatory endpoints of superiority to placebo at two hours for pain freedom and freedom from the migraine-related most bothersome symptom (MBS).

During the trials, patients identified their most bothersome symptom other than pain from a list comprising nausea, heightened sensitivity to light (photophobia) and heightened sensitivity to sound (phonophobia).

In the third phase trial, zavegepant demonstrated broad efficacy by showing statistically significant superiority to placebo across a total of 15 prespecified primary and secondary outcome measures, including multiple ultra-rapid onset endpoints such as 15 minute pain relief and return to normal function in 30 minutes, and multiple durable efficacy endpoints such as 2-24 hour and 2-48 hour sustained pain freedom and sustained pain relief.

Albert Einstein College of Medicine professor and vice chair of neurology and Montefiore Headache Center director Richard B. Lipton said: “Many patients with migraine need treatments other than pills for at least some of their attacks. Swallowing a pill may make nausea worse and if the patient vomits, medication cannot be absorbed.

“Nasal sprays are a favoured option to tablets in many situations. In addition, many patients dissatisfied with their current acute treatments want faster relief so they can get back to their plans without missing life’s important moments. Zavegepant nasal spray will be an important option for patients seeking nonoral therapies and faster relief.  Though head to head studies are lacking, relative to triptan nasal sprays, zavegepant should provide favourable safety and tolerability, lack of cardiovascular contraindications and precautions and a reduced risk of medication overuse.”