Biopharmaceutical company AbbVie, Inc. (ABBV) announced Wednesday positive topline results from its Phase 3 TEMPLE multicenter, randomized, double-blind, head-to-head study evaluating the tolerability, safety and efficacy of atogepant (QULIPTA/AQUIPTA, 60 mg once daily) compared to the highest tolerated dose of topiramate (50, 75 or 100 mg/day) for the preventive treatment of migraine in adult patients with a history of four or more migraine days per month.
Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist, while topiramate is an anticonvulsant medication also approved for migraine prevention.
Atogepant met the primary endpoint of fewer treatment discontinuations attributed to adverse events versus topiramate, and all six secondary endpoints achieved statistical significance for superiority versus topiramate, demonstrating clinical efficacy.
Over the 24-week double-blind treatment period, discontinuation due to AEs was significantly lower with atogepant at 12.1%, compared to topiramate at 29.6%.
The study also met all six secondary endpoints, including a key measure of clinical efficacy, with 64.1% of patients on atogepant achieved a =50% reduction in mean monthly migraine days during months 4 to 6 of the double-blind treatment period compared to 39.3% of patients on topiramate.
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