AbbVie Announces New Data Demonstrating Atogepant (QULIPTA® / AQUIPTA®) Achieves Superiority Across All Endpoints in Phase 3 Head-to-Head Study Compared to Topiramate for Migraine Prevention

Core Insights - AbbVie announced positive topline results from its Phase 3 TEMPLE study, demonstrating that atogepant (QULIPTA® / AQUIPTA®, 60 mg once daily) is more tolerable and effective than topiramate for migraine prevention in adults with a history of four or more migraine days per month [1][4][5] Group 1: Study Results - The study met its primary endpoint, showing a significantly lower discontinuation rate due to adverse events (AEs) with atogepant (12.1%) compared to topiramate (29.6%), resulting in a relative risk of 0.41 (95% CI: 0.28, 0.59; p<0.0001) [1][4][6] - All six secondary endpoints were met, with 64.1% of patients on atogepant achieving a ≥50% reduction in mean monthly migraine days during months 4 to 6, compared to 39.3% for topiramate (p<0.0001) [1][4][5] Group 2: Study Design - The TEMPLE study was a Phase 3, multicenter, randomized, double-blind, active-controlled trial involving 545 participants aged 18 and older across 73 sites in Europe, Israel, and Canada [3][4] - The study included a 24-week double-blind treatment period followed by a 52-week open-label treatment period, where all participants received atogepant [5][6] Group 3: Industry Context - Migraine affects approximately 14% of the global population and is the second leading cause of disability worldwide, indicating a significant unmet need for effective preventive treatments [1][2] - Over 50% of individuals currently using preventive medications still qualify for further treatment, highlighting gaps in patient care and the need for improved therapeutic options [1][2][3]