Atogepant Reduces Monthly Migraine Days in Phase 3 Prevention Trial

The ADVANCE study included 910 adults who experienced 4 to 14 migraines per month.

Positive results were announced from a phase 3 study evaluating the efficacy and safety of atogepant (AbbVie), an investigational oral calcitonin gene-related peptide (CGRP) receptor antagonist, for the prevention of migraine in patients with episodic migraine.

The pivotal, multicenter, double-blind, placebo-controlled ADVANCE study included 910 adults who experienced 4 to 14 migraines per month. Patients were randomized to 1 of 4 treatment arms: atogepant 10mg, 30mg, or 60mg orally once daily, or placebo. The primary end point was the change from baseline in mean monthly migraine days across the 12-week treatment period.

Findings from the study showed statistically significantly greater decreases in mean monthly migraine days with atogepant compared with placebo (3.69 days with 10mg, 3.86 days with 30mg and 4.2 days with 60mg vs 2.48 days with placebo; P ≤.0001). Moreover, a greater proportion of patients treated with atogepant (10mg/30mg/60mg) achieved a ≥50% reduction in mean monthly migraine days (key secondary end point) across the 12-week treatment period compared with placebo (55.6%/58.7%/60.8%, respectively, vs 29.0%; P ≤.0001). 

Additionally, atogepant 30mg and 60mg doses were associated with statistically significant improvements in other secondary end points including change from baseline in mean monthly headache days, mean monthly acute-medication use days, and mean monthly performance of daily activities and physical impairment domain scores of the Activity Impairment in Migraine-Diary (AIM-D), and change from baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Role Function-Restrictive domain score at week 12. The 10mg dose of atogepant resulted in statistically significant improvements in 4 of the 6 secondary end points.

The safety profile of atogepant was consistent with that seen in previous studies. The most common adverse events (≥5% greater than placebo) were constipation (6.9-7.7% across all doses vs 0.5% for placebo), nausea (4.4-6.1% across all doses vs 1.8% for placebo), and upper respiratory tract infections (3.9-5.7% across all doses vs 4.5% for placebo). There were no serious adverse events reported in the 30mg or 60mg treatment arms.

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Data from the phase 3 ADVANCE study and the phase 2/3 CGP-MD-01 study will form the basis of the Company’s regulatory submission. “With the results from these trials, we aim to provide a safe and effective preventive treatment that offers patients and healthcare providers a simple, once daily oral treatment that works specifically by blocking CGRP receptors and preventing migraine,” said Thomas J. Hudson, MD, Senior Vice President of R&D and Chief Scientific Officer, AbbVie.

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1. AbbVie announces positive phase 3 data for atogepant in migraine prevention. Published July 29, 2020. Accessed July 30, 2020.