PHILADELPHIA —The high-affinity antagonist to the calcitonin gene-related peptide receptor, atogepant, was found to be safe and effective for reducing the mean monthly migraine days, according to a study presented at the 61st Annual Scientific Meeting of the American Headache Society, held July 11 to 14 in Philadelphia, Pennsylvania.
“Migraine attacks are very disabling, and a substantial issue with current preventives is poor tolerability and thus patchy adherence,” lead study author and presenter, Peter Goadsby, MD, of King’s College London, told Clinical Pain Advisor. “Atogepant oral preventives will very much get around those issues.”
In this multicenter placebo-controlled parallel-group AGN-241689 trial (Clinicaltrials.gov identifier: NCT02848326), patients with a history of migraine with or without aura who experienced 4 to 14 migraine days during the study’s 28-day baseline period were recruited.
Patients were randomly assigned to receive placebo twice daily, oral atogepant (AGN-241689) at 10, 30, or 60 mg once daily every day plus placebo once daily, or oral atogepant 30 or 60 mg twice daily over a 12-week period.
The change in the mean monthly migraine days from baseline was the study’s primary efficacy end point. The researchers also evaluated safety and tolerability. The efficacy population and safety population consisted of 795 patients and 825 patients, respectively (mean age, 40.1 years; 76.1% white; 86.5% women; no prior migraine prophylactic, 71.9%). At baseline, the mean number of migraine days were 7.67±2.49.
At 12 weeks, the mean changes in monthly migraine days compared with placebo (-2.85) were: atogepant 10 mg every day (-4.00; P =.0236), atogepant 30 mg every day (-3.76; P =.0390), atogepant 30 mg twice daily (‐4.23; P =.0034), atogepant 60 mg every day (-3.55; P =.0390), and atogepant 60 mg twice daily (‐4.14; P =.0031). A total of 480 participants (58.2%) reported treatment-emergent adverse events, 20.6% of which were considered to be related to treatment. None of the 7 cases (0.8%) of serious adverse events were considered treatment related.
“The development of an oral mechanism-specific migraine preventive treatment will be nothing short of revolutionary,” noted Dr Goadsby. “The reason being is that oral medicines are more likely to be prescribed in general neurology and eventually primary care for migraine prevention than monoclonal antibodies given by injection. They will not be first line, offering instead a way forward for patients with disabling migraine who have not responded to or not tolerated other preventives.”
Goadsby P, Dodick D, Ailani J, et al. Orally administered atogepant was efficacious, safe, and tolerable for the prevention of migraine: results from a phase 2b/3 study. Presented at: 61st Annual Scientific Meeting of the American Headache Society, July 11-14, 2019, Philadelphia, PA. Abstract 629248.