Positive results were announced from a phase 3 study evaluating atogepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist, for the preventive treatment of chronic migraine in adults.
The global, randomized, double-blind, placebo-controlled, parallel-group PROGRESS study (ClinicalTrials.gov Identifier: NCT03855137) compared the efficacy and safety of atogepant to placebo in 778 adults with at least a 1-year history of chronic migraine, and at least 15 headache days with at least 8 migraine days in the 28 days prior to randomization. Patients were randomly assigned to 1 of 3 treatment groups: atogepant 60mg once daily (QD), atogepant 30mg twice daily (BID), or placebo, across a 12-week treatment period.
Among the 755 evaluable patients in the US-focused modified intent-to-treat (mITT) population, results showed that patients in the atogepant 60mg QD and 30mg BID treatment arms experienced a statistically significant reduction from baseline in mean monthly migraine days (primary endpoint) of 6.88 (P =.0009) and 7.46 (P <.0001) days, respectively, vs 5.05 days in the placebo arm.
Additionally, in the mITT population, 41% and 42.7% of patients in the atogepant 60mg QD and 30mg BID treatment arms, respectively, achieved at least a 50% reduction in mean monthly migraine days (secondary endpoint) compared with 26% of patients in the placebo arm (P ≤.0009).
The safety profile of atogepant was found to be consistent with that seen in previous studies in an episodic migraine population. The most common adverse events reported were constipation and nausea.
Atogepant is currently marketed under the brand name Qulipta and is approved for the preventive treatment of episodic migraine. AbbVie intends to submit a supplemental New Drug Application to the Food and Drug Administration (FDA) to expand the use of atogepant to include the preventive treatment of chronic migraine.
AbbVie announces positive phase 3 atogepant (Qulipta™) data for the preventive treatment of chronic migraine. News release. AbbVie. Accessed March 10, 2022. https://www.prnewswire.com/news-releases/abbvie-announces-positive-phase-3-atogepant-qulipta-data-for-the-preventive-treatment-of-chronic-migraine-301500085.html