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

Published: 2025-06-18 10:05:34 ET ABBV

Published on 06/18/2025 at 10:05

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 (QULIPTA®? /AQUIPTA®?, 60 mg once daily) compared to the highest tolerated dose of topiramate (50, 75 or 100 mg/day) 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 The study also met all six secondary endpoints, including a key measure of clinical efficacy: 64.1% of patients on atogepant achieved a 50% reduction in mean monthly migraine days (MMD) during months 4 to 6 of the double-blind treatment period compared to 39.3% of patients on topiramate (p A type of circulation problem can worsen or happen. Raynaud's phenomenon can lead to your fingers or toes feeling numb, cool, or painful, or changing color from pale, to blue, to red. The most common side effects of QULIPTA are nausea, constipation, and fatigue/sleepiness.

These are not all the possible side effects of QULIP TA. QULIPTA is available in 10 mg, 30 mg, and 60 mg tablets.