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Abstract Details

Zavegepant Intranasal Spray for the Acute Treatment of Migraine: A Systematic Review and Meta-analysis of Randomized Clinical Trials
Headache
S22 - Advances in Migraine and Therapeutics (2:12 PM-2:24 PM)
007
Zavegepant, a third generation small-molecule CGRP receptor antagonist, is the first intranasally administered option and was recently approved by the FDA. This highly selective and potent competitive CGRP receptor antagonist possesses remarkable aqueous solubility, making it suitable for nasal delivery, and demonstrates excellent oxidative stability 
To evaluate the safety and efficacy of zavegepant, a recently approved third-generation small-molecule calcitonin gene-related peptide receptor antagonist, administered as a nasal spray (BHV-3500) for the acute treatment of migraine attacks.

A comprehensive search was conducted across multiple databases to identify relevant randomized clinical trials (RCTs). Two RCTs, involving a total of 2850 participants, were selected for quantitative analysis. An additional trial was included for qualitative synthesis. The primary efficacy outcome assessed was freedom from pain at 2 hours post-dose. Safety outcomes were evaluated based on adverse events (AEs), with zavegepant 10 mg and placebo groups compared for incidence of AEs.

The analysis shows that zavegepant 10 mg exhibited a significantly higher likelihood of achieving freedom from pain at 2 hours post-dose compared to the placebo group (RR 1.54, 95% CI 1.28 to 1.84). Additionally, zavegepant 10 mg demonstrated superior freedom from the most bothersome symptoms (MBS) at 2 hours post-dose compared to placebo (RR 1.26, 95% CI 1.13 to 1.42). However, the zavegepant 10 mg group experienced a higher incidence of adverse events compared to placebo (RR 1.78, 95% CI 1.5 to 2.12), with dysgeusia being the most reported AE (RR 4.18, 95% CI 3.05 to 5.72).

According to our analysis,zavegepant 10 mg was more effective than placebo for treatment of acute migraine attacks.This provides compelling evidence that zavegepant is an effective acute treatment option for migraine, effectively relieving migraine pain, and most bothersome symptoms. Real-world studies are needed to confirm the efficacy, tolerability, and safety in clinic-based settings consisting of heterogeneous patient populations. 
Authors/Disclosures
Mainak Bardhan, MD (Miami Cancer Institute, Baptist Health South Florida)
PRESENTER 		Dr. Bardhan has nothing to disclose.
Vinay Suresh Mr. Suresh has nothing to disclose.
Tirth Dave Mr. Dave has nothing to disclose.
Muhammad Aaqib Shamim No disclosure on file
Dilip Suresh Mr. Suresh has nothing to disclose.
Poorvikha S No disclosure on file
Bishal Dhakal Bishal Dhakal has nothing to disclose.
Aman M. Bhonsale (All India Institute of Medical Sciences, Nagpur) Mr. Bhonsale has nothing to disclose.
Priyanka Roy (Directorate of Factories,Department of Labour Government of West Bengal,India) No disclosure on file
Teshamae Monteith, MD, FAAN (University of Miami) Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for American Headache Society . Dr. Monteith has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for e-Neura. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Monteith has received personal compensation in the range of $0-$499 for serving as a Consultant for Merz. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva . Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for AAN . Dr. Monteith has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for AAN. Dr. Monteith has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for AAN . The institution of Dr. Monteith has received research support from AbbVie. The institution of Dr. Monteith has received research support from Amgen. The institution of Dr. Monteith has received research support from lilly. The institution of Dr. Monteith has received research support from Ipsen. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Education with Medscape. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Education with Massachusetts Medical Society . Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Education with Academic CME. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Neuodiem. Dr. Monteith has a non-compensated relationship as a President Elect with Florida Society of Neurology that is relevant to AAN interests or activities. Dr. Monteith has a non-compensated relationship as a Editorial Board with American Migraine Foundation that is relevant to AAN interests or activities. Dr. Monteith has a non-compensated relationship as a Board Member with International Headache Society that is relevant to AAN interests or activities. Dr. Monteith has a non-compensated relationship as a author with Pfizer that is relevant to AAN interests or activities. Dr. Monteith has a non-compensated relationship as a author with Abbvie that is relevant to AAN interests or activities. Dr. Monteith has a non-compensated relationship as a author with Theranica that is relevant to AAN interests or activities.