Allergan has reported positive results from CGP-MD-01, a Phase 2b/3 clinical trial evaluating the efficacy, safety and tolerability of its orally administered migraine treatment, atogepant.
All active treatment arms of atogepant met the primary endpoint across all doses and dose regimens, with a statistically significant reduction from baseline in monthly migraine/probable migraine (MPM) headache days in patients with episodic migraine treated with atogepant compared with placebo for 12 weeks.
Atogepant is Allergan’s second orally-administered investigational calcitonin gene-related peptide (CGRP) receptor antagonist in development for migraine prevention.
Atogepant follows ubrogepant, Allergan’s first oral investigational CGRP antagonist for the acute treatment of migraine, which reported two positive Phase 3 pivotal trial results earlier this year. Allergan will continue with its phase 3 program for atogepant following discussions with regulatory authorities.
“We are extremely pleased to share these positive results for atogepant — our first phase 2b/3 study in Episodic Migraine—which represent a tremendous opportunity in the prevention of migraine, with a convenient, oral dosage form that is currently unavailable,” said David Nicholson, Chief Research and Development Officer, Allergan.
“Allergan has been studying migraine treatment for decades and is committed to addressing unmet needs through product innovation for patients who are hopeful for new options that can make a true difference in their daily lives.”