Atogepant Demonstrates Efficacy and Safety for Prevention of Episodic Migraine
In a phase 2b/3 clinical trial (CGP-MD-01) of the orally administered calcitonin gene-related peptide receptor (CGRP) antagonist, atogepant (Allergan, Ireland), all primary endpoints for all doses and regimens for prevention of episodic migraine have been met. These results suggest that atogepant is effective and safe for the prevention episodic migraine. Allergan plans to continue phase 3 studies of atogepant for prophylaxis in patients with episodic migraine. It is expected that atogepant will be one of the first oral CGRP-related treatments for prevention of migraine.
Patients given atogepant had a mean reduction in the number of headache days per month of -4.00 days (10 mg 1/day, P = 0.32), -3.76 days (30 mg 1/day, P = .23), -3.55 days (60 mg 1/day, P = .23), -4.23 days (30 mg 2/day, P = .35), and -4.14 days (60 mg 2/day, P = 0.33) compared to a reduction of -2.85 mean headache days per month in patients given placebo. The reported P-values are adjusted for multiple comparisons by controlling the overall type I error rate of the study at 5%, 2-sided. Efficacy analyses were based on the modified intention-to-treat population of 795 patients. Migraine days per month was measured in a 4-week period before treatment began, and efficacy was measured as a change from that baseline in the mean number of migraine or probable migraines per month over the 12-week period.
David Nicholson, Chief Research and Development Officer of Allergan noted, “We’re very encouraged by our findings at various dosages for atogepant, because ultimately, what physicians want is dose flexibility and we have enough data to potentially develop multiple dose and dosing regimens. . . we believe we have oral medications that are very effective and competitive to other monoclonal antibodies. Atogepant represents a substantial step forward in therapeutic options for migraine sufferers.”
Atogepant was well tolerated by patients, and the most common adverse events were nausea, fatigue, constipation, nasopharyngitis, and urinary tract infection, reported with a frequency >5% in at least 1 group of patients treated with atogepant and greater than placebo. There was no signs of hepatotoxicity and the liver safety profile for atogepant was similar to placebo.
The President and Chief Executive Officer of Allergan, Brent Saunders, stated, “We’re excited to continue building a strong migraine portfolio, which includes Botox as the first preventive treatment for chronic migraine, and now the potential to advance two oral treatments—atogepant and ubrogepant— that cover a spectrum of migraine diseases. Allergan has been committed to advancing the science of migraine through ongoing research and clinical investment, while providing innovative treatment approaches, educational opportunities, and support services that improve the lives of patients.”