AbbVie reports results from Phase 3 TEMPLE multicenter study

AbbVie (ABBV) announced positive topline results from its Phase 3 TEMPLE multicenter, randomized, double-blind, head-to-head study evaluating the tolerability, safety and efficacy of atogepant, or QULIPTA/AQUIPTA, compared to the highest tolerated dose of topiramate 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, or AEs, demonstrating that atogepant, a calcitonin gene-related peptide, or 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 compared to topiramate, representing a relative risk of 0.41. The study also met all six secondary endpoints, including a key measure of clinical efficacy: 64.1% of patients on atogepant achieved a greater than or equal to50% 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. Migraine continues to be underdiagnosed and undertreated, despite significant burden on patients’ lives. Full results from the TEMPLE study will be presented at an upcoming medical meeting.