AbbVie 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 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 (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).

"These TEMPLE data affirm recommendations from the American Headache Society and International Headache Society, highlighting the role of CGRP pathway inhibitors as first-line preventive treatment options for migraine," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "This study demonstrates our commitment to improving treatment options and advancing care standards for people living with this debilitating disease."

"Far too often, people living with migraine struggle with meeting their treatment goals despite available and accessible preventive options," said Jaclyn Duvall, M.D., neurologist and founder of Headache Specialists of Oklahoma. "The TEMPLE data provide a patient-centered measure of treatment effectiveness by capturing both efficacy and tolerability, representing a meaningful way to evaluate the real-world impact of treatment persistence in migraine prevention."

The AE profile of atogepant observed in this active-controlled study was generally consistent with its established safety profile from prior studies.

Atogepant, marketed as AQUIPTA in the EU and QULIPTA in the U.S., Canada, Israel and Puerto Rico, is approved in 60 countries. Atogepant is a once-daily oral CGRP receptor antagonist, proven to prevent both episodic and chronic migraine in adults.