As declared by a well-established biopharmaceutical company on 29 July, 2020, the Phase 3 ADVANCE trial examining the investigational medicine atogepant was successful in fulfilling its primary endpoint of statistically meaningful greater decrease in monthly migraine days on an average than placebo, for all the doses across the 12-week treatment duration.

The M.D of the company noted, “Considering the trial outcomes, an effective and safe preventive therapy for patients and healthcare providers will be useful as an easy, oral therapy QD which work by obstructing CGRP receptors and averting migraine will be issued.”

The efficacy, safety, and tolerability of oral atogepant for migraine prevention in those with 4 to 14 migraine days monthly were assessed in this pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial.

Overall, 910 patients were divided into 4 treatment groups i.e. atogepant 10 mg, 30 mg, or 60 mg QD, or placebo. The efficacy evaluates were as per the altered intent-to-treat (mITT) of 873 patients. Change from baseline in mean monthly migraine days in 12 weeks was considered as a primary endpoint. All the doses of atogepant fulfilled the primary endpoint criteria and displayed statistically noteworthy greater decreases in monthly migraine days on an average than placebo.

Patients treated with atogepant 10 mg, 30 mg, 60 mg, and patients receiving placebo experienced a decrease in days, as shown in the following table:

The percentage of patients attaining 50% decrease is shown in the following table:

At week 12, the change from baseline in average headache days, mean acute-medicine use days, and mean performance of daily activities, in a month and; physically diminishing domain scores of the Activity Impairment in Migraine-Diary (AIM-D), and variation from baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Role Function-Restrictive domain score were all calculated. The doses of 30 mg and 60 mg, lead to statistically significant improvements in all secondary endpoints, whereas 10 mg dose lead to statistically significant improvements in 4/6 secondary endpoints.

Concerning safety, serious adverse events arose in patients in the atogepant 10 mg arm and the placebo arm. But, no serious adverse events were observed in 30 mg or 60 mg atogepant group,

Usually, adverse events described with a rate ≥ 5% in at least 1 atogepant treatment dose group, and greater than placebo, were constipation, nausea and upper respiratory tract infection (mostly mild or moderate). No hepatic safety concerns were recognized.

In June 2018, the Phase 2/3 CGP-MD-01 Study results confirming the efficacy of atogepant fulfilling the primary endpoint with a notable decrease from baseline in mean monthly migraine days than placebo across during 12 weeks were announced.