AbbVie’s atogepant achieves superiority in migraine prevention

US pharma major AbbVie (NYSE: ABBV) today announced positive top-line results from its Phase III TEMPLE multicenter, randomized, double-blind, head-to-head study evaluating the tolerability, safety and efficacy of atogepant (trade name Aquipta, 60mg once daily) compared to the highest tolerated dose of topiramate (50, 75 or 100mg/day) in adult patients with a history of four or more migraine days per month.

The study met the primary endpoint of treatment discontinuation due to adverse events (AEs), demonstrating that atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, had fewer discontinuations due to AEs than topiramate, an anticonvulsant medication also approved for migraine prevention. Over the 24-week double-blind treatment period, discontinuation due to AEs was significantly lower with atogepant (12.1%) compared to topiramate (29.6%), representing a relative risk of 0.41 (95% CI: 0.28, 0.59; p<0.0001).

The study also met all six secondary endpoints, including a key measure of clinical efficacy: 64.1% of patients on atogepant achieved a ≥50% reduction in mean monthly migraine days (MMD) during months 4 to 6 of the double-blind treatment period compared to 39.3% of patients on topiramate (p<0.0001). The AE profile of atogepant observed in this active-controlled study was generally consistent with its established safety profile from prior studies.