Long-term safety and tolerability of atogepant in migraine

Results from an open-label extension study of the ADVANCE trial were consistent with the established safety profile of atogepant [1]. No new safety signals, hepatic safety issues, nor deaths were reported in this trial. These results support the long-term safety and tolerability of atogepant once daily.

Atogepant is an oral small-molecule calcitonin gene-related peptide (CGRP)-receptor antagonist under investigation for the preventive treatment of migraine. Daily atogepant administration was shown to be safe and effective in the preventive treatment of episodic migraine in 2 placebo-controlled, double-blind, randomised clinical trials: a phase 2b/3 study (NCT02848326) and the phase 3 ADVANCE trial (NCT03777059) [2,3].

The current open-label extension study (NCT03939312) investigated the long-term safety and tolerability of 60 mg atogepant over 40 weeks in participants who completed the pivotal 12-week ADVANCE trial [1]. The safety population included 685 patients who took ≥1 dose study drug, of whom 74.6% completed the 40-week treatment period. Prof. Laszlo Mechtler (DENT Neurologic Institute, NY, USA) presented the data.

Mean age of participants was 41.8 years, 88.2% were women, 84.4% were white, and mean BMI was 30.6 kg/m². Concerning the diagnosis, 16.5% had migraine with aura, 43.9% had migraine without aura, and 39.6% had both.

After a treatment duration of mean 233.6 days, a treatment-emergent adverse event (AE) was reported in 62.5% of participants, of which 8.8% was considered treatment-related by the investigator. Serious AEs occurred in 3.4% of participants, of which none were considered treatment-related.

1. Mechtler L, et al. Evaluation of the Long-Term Safety and Tolerability of Oral Atogepant 60 mg Once Daily for Preventive Treatment of Migraine: A Phase 3, 40-Week, Multicenter Extension to the Advance Trial. AL077, IHC 2021, 8–12 September.
2. Goadsby PJ, et al. Lancet Neurol. 2020;19(9):727–37.
3. Schwedt TJ, et al. Cephalalgia, Sep 14, 2021. DOI: 10.1177/03331024211042385.

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Posted on 8 November 20211 February 2024