AbbVie Reveals Phase 3 Data Showing Atogepant's Superiority Over Topiramate in Migraine Prevention

AbbVie recently disclosed promising top-tier results from its Phase 3 TEMPLE study, which assessed the tolerability, safety, and efficacy of atogepant compared to topiramate for migraine prevention in adults. This multicenter, randomized, double-blind, head-to-head trial aimed to prevent migraines in patients who experience four or more migraine days monthly. Atogepant, a CGRP receptor antagonist, was evaluated against topiramate, an anticonvulsant used for migraine prevention.

The TEMPLE study successfully achieved its primary endpoint by demonstrating that atogepant led to fewer treatment discontinuations caused by adverse events. Specifically, during the 24-week treatment period, discontinuation rates due to adverse effects were significantly lower for patients taking atogepant (12.1%) compared to those on topiramate (29.6%). This indicates a relative risk of 0.41, underscoring atogepant's improved tolerability. Furthermore, all six secondary endpoints were met, including a ≥50% reduction in mean monthly migraine days, achieved by 64.1% of patients using atogepant compared to 39.3% for topiramate users.

Dr. Roopal Thakkar, AbbVie's Executive Vice President of Research and Development and Chief Scientific Officer, emphasized the importance of these findings. The data confirm recommendations from prominent headache societies, advocating for CGRP pathway inhibitors as leading preventive treatments for migraines. This aligns with AbbVie's goal to enhance migraine treatment options and elevate standards of care.

Migraines, affecting approximately 14% of the global population, remain profoundly underdiagnosed and undertreated, despite being the second leading cause of disability worldwide. Although preventive medications are available, more than half of the users still require additional treatment to achieve sufficient relief, highlighting current gaps in patient care.

Dr. Jaclyn Duvall, a neurologist and founder of Headache Specialists of Oklahoma, highlighted the struggle many migraine sufferers face in achieving their treatment goals. She noted that the TEMPLE study offers a patient-focused assessment of treatment effectiveness, capturing both efficacy and tolerability, which is vital for evaluating real-world impact.

The adverse event profile for atogepant observed in the study was consistent with prior safety information. Known as QULIPTA® in the U.S., Canada, Israel, Puerto Rico, and AQUIPTA® in the EU, atogepant is approved in 60 countries and functions as a once-daily oral CGRP receptor antagonist to prevent both episodic and chronic migraines.

The TEMPLE trial involved 545 participants aged 18 and older across 73 global sites. It was conducted in two phases: the initial 24-week Double-Blind Treatment Period, which included a 6-week up-titration phase and an 18-week maintenance phase, while participants received either atogepant or the highest tolerated dose of topiramate. Subsequently, eligible participants entered a 52-week Open-Label Treatment Period, where all received atogepant. Throughout, patient-reported outcomes were consistently collected, and safety and tolerability were monitored via clinical assessments and laboratory tests.

Overall, the TEMPLE study reinforces the potential benefits of atogepant for migraine prevention, providing meaningful data that may pave the way for improved patient outcomes and more effective management of migraine symptoms. Full results from this pivotal study are scheduled to be presented at an upcoming medical conference.