Atogepant efficacious, safe, and well-tolerated for migraine prevention

In a phase 2b/3 trial the efficacy, safety, and tolerability of atogepant vs placebo for prevention of episodic migraine were evaluated. The results of this novel, oral CGRP receptor antagonist indicate that atogepant can be an effective and safe migraine treatment for patients who experience <15 headache days per month.

In this multicentre, double-blind, placebo-controlled, parallel-group trial, 834 adult migraine patients, with or without aura, and with 4-14 migraine days in the 28-day baseline period, were randomised 2:1:2:1:2:1 to 12 weeks of treatment with placebo, atogepant 10 mg once-daily, 30 mg once-daily, 30 mg twice-daily, 60 mg once-daily, or 60 mg twice-daily, respectively.

Mean baseline monthly migraine days (MMDs) were 7.67. Reductions from baseline in the mean MMD for all 5 atogepant treatment groups were statistically significant compared with reductions in the placebo group after 12 weeks. Mean change in MMDs was for placebo: -2.85, atogepant 10 mg once-daily: -4.00 (P=0.0236), 30 mg once-daily: -3.76 (P=0.0390), 30 mg twice-daily: -4.23 (P=0.0034), 60 mg once-daily; -3.55 (P=0.0390), 60 mg twice-daily: -4.14 (P=0.0031). The proportion of subjects with a 25%, 50%, 75%, and 100% reduction from baseline in MMDs favoured atogepant.

Atogepant was also well-tolerated. Treatment-emergent adverse events were reported by 480 subjects (58.2%); 22% of atogepant and 16% of placebo patients reported adverse events that were considered treatment-related. A total of 7 subjects (0.8%) reported serious adverse events, none considered treatment-related. There were 10 cases of treatment-emergent ALT/AST elevations >3 times the upper limit of normal, balanced across groups. Only 1 out of 10 cases (atogepant) was considered probably related.

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   1. Goadsby P, et al. EAN 2019, EPO3117.

Posted on 27 August 201917 March 2021