AbbVie's Atogepant Tops Topiramate In Migraine Study, Showing Fewer Side Effects And Stronger Efficacy

AbbVie has announced positive topline results from its Phase 3 TEMPLE trial, a head-to-head study evaluating its migraine prevention drug atogepant (QULIPTA®/AQUIPTA®) against topiramate, a widely used anticonvulsant also approved for migraine. The multicenter, randomized, double-blind trial enrolled adults who experienced four or more migraine days per month. Over a 24-week period, the study's primary endpoint was met, showing that patients on atogepant discontinued treatment due to adverse events (AEs) significantly less often than those on topiramate, 12.1% vs. 29.6% respectively (p<0.0001).

"Far too often, people living with migraine struggle with meeting their treatment goals despite available and accessible preventive options. 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," said Jaclyn Duvall, M.D., neurologist and founder of Headache Specialists of Oklahoma. 

Atogepant also outperformed topiramate across all six secondary endpoints, including a critical measure of clinical efficacy. Nearly two-thirds (64.1%) of patients treated with atogepant achieved a reduction of at least 50% in their average monthly migraine days during months 4 to 6, compared to only 39.3% of patients treated with topiramate. These results underscore the potential for atogepant to deliver improved tolerability and sustained efficacy in a population for whom migraine remains a significant and often inadequately managed burden.

"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. This study demonstrates our commitment to improving treatment options and advancing care standards for people living with this debilitating disease," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. 

Migraine is a complex neurological disorder affecting around 14% of the global population, yet it remains significantly underdiagnosed and undertreated. Despite available therapies, over half of those receiving preventive treatment still experience inadequate symptom control. Atogepant, already approved in over 60 countries, is a once-daily oral CGRP receptor antagonist indicated for both episodic and chronic migraine. The safety profile of atogepant in the TEMPLE study was consistent with previous clinical data, further reinforcing its position as a well-tolerated, effective treatment option.