2024 American Academy of Neurology Abstract Website

Mainak Bardhan¹, Vinay Suresh², Tirth Dave³, Muhammad Aaqib Shamim⁴, Dilip Suresh⁵, Poorvikha Satish⁶, Bishal Dhakal⁷, Aman Bhonsale⁸, Priyanka Roy⁹, Teshamae Monteith¹⁰
¹Neuro Medical Oncology, Miami Cancer Institute,Baptist Health South Florida, ²King George's Medical University, ³Bukovinian State Medical University, ⁴All India Institute of Medical Science - Jodhpur, ⁵Madras Medical College, ⁶St John’s Medical College, ⁷Bardibas Field Hospital, Nepalese Army Institute of Health Sciences, ⁸All India Institute of Medical Sciences, Nagpur, ⁹Directorate of Factories, Department of Labour, Government of West Bengal, ¹⁰Neurology, University of Miami, Millar school of Medicine

Objective:

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.

Background:

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

Design/Methods:

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.

Results:

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).

Conclusions:

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.