Allergan: Atogepant Shows Robust Efficacy, Safety In Phase 2b/3 Trial

(RTTNews) - Allergan plc (AGN) announced positive results from CGP-MD-01, a Phase 2b/3 clinical trial evaluating the efficacy, safety, and tolerability of orally administered atogepant, a highly potent CGRP receptor antagonist in development for the prevention of migraine. The company said 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 headache days in patients with episodic migraine treated with atogepant compared with placebo for 12 weeks.

In the CGP-MD-01 trial, atogepant was well tolerated. There was no signal of hepatotoxicity with atogepant in the study with daily administration over 12 weeks. The liver safety profile for atogepant was similar when compared to placebo.

Allergan said the company will continue with its phase 3 program for atogepant following discussions with regulatory authorities.