Atogepant Demonstrates Significant Efficacy in Phase 3 Trial: Over Half of Patients Achieve ≥50% Reduction in Monthly Migraine Days

AbbVie recently announced that the results of its Phase 3 clinical trial evaluating atogepant, an investigational CGRP receptor inhibitor, for the prevention of episodic migraine have been published in *The New England Journal of Medicine*. The trial results showed that all atogepant dose groups met the primary endpoint, demonstrating a significant reduction in the mean number of monthly migraine days over the 12-week treatment period compared with placebo. The study also found that a greater proportion of subjects in the atogepant groups achieved at least a 50% reduction in mean monthly migraine days compared with placebo.

Atogepant, an investigational oral calcitonin gene-related peptide (CGRP) receptor antagonist, is currently under review by the U.S. FDA. CGRP and its receptor are expressed in regions of the nervous system associated with the pathophysiology of migraine. Studies have shown that CGRP levels are elevated during migraine attacks, and selective CGRP receptor antagonists can provide clinical benefits to patients with migraine.

The primary endpoint of the Phase 3 clinical trial was the change from baseline in monthly mean migraine days during the 12-week treatment period. All atogepant dose groups met the primary endpoint. Compared with patients in the placebo group (a reduction of 2.5 days), those in the 10 mg, 30 mg, and 60 mg atogepant groups had reductions of 3.7, 3.9, and 4.2 days, respectively (p < 0.0001 for all dose groups versus placebo).

▲ Atogepant Molecular Structure (Image source: PubChem)

The clinical trial also met multiple key secondary endpoints, including that during the 12-week treatment period, 55.6%, 58.7%, and 60.8% of patients in the 10 mg, 30 mg, and 60 mg atogepant groups, respectively, achieved a ≥50% reduction in monthly migraine days, compared with 29.0% in the placebo group (p<0.0001 for all dose groups vs. placebo).

Regarding safety and tolerability, all doses were well tolerated. The most common adverse events were constipation (6.9–7.7% across all dose groups vs. 0.5% in the placebo group), nausea (4.4–6.1% across all dose groups vs. 1.8% in the placebo group), and upper respiratory tract infection (3.9–5.7% across all dose groups vs. 4.5% in the placebo group). Most cases of constipation, nausea, and upper respiratory tract infection were mild or moderate in severity and did not result in discontinuation.

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References:

[1] New England Journal of Medicine Publishes 12-Week Results from Study Evaluating Atogepant for the Preventive Treatment of Migraine. Retrieved August 21, 2021, from https://news.abbvie.com/news/press-releases/new-england-journal-medicine-publishes-12-week-results-from-study-evaluating-atogepant-for-preventive-treatment-migraine.htm

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