Pfizer Launches Phase III Clinical Trial of Zavegepant Nasal Spray for Acute Migraine Treatment in China

On August 10, Pfizer registered a Phase III study (CTR20232410) on Clinicaltrials.gov for the new migraine drug Zavegepant nasal spray for the acute treatment of migraines with or without aura in adults.

This study is a randomized, double-blind, parallel-group, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of Zavegepant nasal administration for the acute treatment of migraine in Asian adult patients. It plans to enroll 980 patients in China and 1400 adult patients from other countries.

This study will also collect information on the onset time, duration of pain relief, and recovery of functional disability related to intranasal administration of Zavegepant.

Zavegepant is a highly selective, high-affinity, structurally unique third-generation small molecule calcitonin gene-related peptide (CGRP) receptor antagonist. Pfizer has developed two formulations of Zavegepant: a nasal spray and an oral formulation. On March 10, 2023, the FDA approved the nasal spray formulation of Zavegepant (ZAVZPRET) for the acute treatment of migraine in adults with or without aura. ZAVZPRET is the first and only approved nasal spray calcitonin gene-related peptide (CGRP) receptor antagonist to reach the market.

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