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Allergan’s Atogepant Meets Migraine Prevention Endpoints

Oral CGRP reduced migraine days in Phase 2B/3 trial

A PPM Brief

Allergan’s (Dublin, Ireland) oral calcitonin gene-related peptide for migraine prevention has met its Phase 2b/3 primary endpoint for all doses and dose regimens, according to a company release.1

The receptor antagonist, atogepant, differs from some of the monoclonal antibodies being developed for administration via IV or injection (Read about Amgen/Novartis’ recently approved Aimovig and the others in development), in that it is metabolized through the liver. Previous trials with the oral gepant molecules have raised liver toxicity concerns. However, this latest trial by Allergan showed that atogepant was “well tolerated and there was no signal of hepatotoxicity with daily administration over 12 weeks.”

The multicenter, randomized, double-blind, placebo-controlled, parallel-group study was conducted in the United States. Subjects (n = 834) were 18 to 75 years of age (inclusive), had a history of migraine with or without aura for at least 1 year, and experienced between 4 to 14 migraine/probable migraine headache days per month on average in the 3 months prior to Visit 1 and in the 28-day baseline period, stated the release. Of interest, 86.5% of the subjects were female – common literature cites that females experience migraine nearly 3 times as often as men.

According to Allergan, “all active treatment groups demonstrated a statistically significant reduction from baseline in the primary efficacy parameter (10 mg QD vs placebo, p = 0.0236; 30 mg QD vs placebo, p=0.0390; 60 mg QD vs placebo, p = 0.0390; 30 mg BID vs placebo; p = 0.0034, 60 mg BID vs placebo, p = 0.0031).” 

Allergan plans to continue its Phase 3 study after regulatory discussions. The company is also developing the CGRP antagonist ubrogepant for the acute treatment of migraine, with an NDA likely to be filed in 2019. Update 3/11/19: Allergan announced the FDA Acceptance of their NDA for Ubrogepant. A PDUFA date has been set by the FDA for Q4 2019. Click here to learn more.

Read more from Allergan in PPM’s exclusive roundtable on the Migraine Game-Changers.

Last updated on: March 19, 2019
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