General Information

• The maximum dose that may be given in a 24-hour period is 10 mg (one spray). 
• The safety of treating more than 8 migraines in a 30-day period has not been established.

Mechanism of Action

Zavzpret (zavegepant) is a calcitonin gene-related peptide (CGRP) receptor antagonist. CGRP is a potent neuromodulator and vasodilator and has been implicated in the pathogenesis of migraine.

Side Effects

Adverse effects associated with the use of Zavzpret may include, but are not limited to, the following:

• taste disorders
• nausea
• nasal discomfort
• vomiting

Clinical Trial Results

The FDA approval of Zavzpret was based on two pivotal randomized, double-blind, placebo-controlled studies that established the efficacy, tolerability and safety profiles of Zavzpret for the acute treatment of migraine. In these studies, Zavzpret was statistically superior to placebo on the co-primary endpoints of pain freedom (defined as a reduction of moderate or severe headache pain to no headache pain) and freedom from most bothersome symptom at two hours post-dose (defined as the absence of the self-identified most bothersome symptom). In the pivotal Phase 3 study, 1,405 people were randomized to receive a single 10 mg dose of either zavegepant or placebo. Participants historically experienced two to eight moderate or severe migraine attacks per month, and their untreated attacks lasted a mean of 30.8 hours. Zavzpret showed broad efficacy by also demonstrating statistically significant superiority to placebo across 13 of 17 prespecified secondary outcome measures, including early time point endpoints (e.g., 15 and 30-minute pain relief and return to normal function at 30 minutes), return to normal function at 2 hours, and durable efficacy endpoints (e.g., 2-24 and 2-48 hour sustained pain freedom and sustained pain relief). On the 14th endpoint, return to normal function at 15 minutes post-dose, the difference between Zavzpret and placebo was not significant.