Phase 3 Results for Ubrogepant for Treatment of Patients With Migraine
At the American Academy of Neurology meeting in Los Angeles, CA, researchers Joel Trugman, Michell Finnegan, Richard Lipton and others presented results from a phase 3 study on ubrogepant (Allergan, Dublin, Ireland) for acute treatment for patients with a single migraine attack. The efficacy, safety, and tolerability of ubrogepant for the acute treatment of migraine (ACHIEVE 1) study enrolled 1,672 subjects and assigned 1,436 to a safety group and 1,327 to treatment groups. Subjects mean age was 40.7 years and the majority of patients were female (87.5%) and Caucasian (82.4%). Migraine behavioral symptoms identified at the time of treatment included photophobia (56.4%), phonophobia (22.3%), and nausea (20.9%).
Patients treated at the time of symptom appearance with either 50 mg or 100 mg of ubrogepant experienced freedom from symptoms and pain significantly more than those treated with placebo. The percentage of patients treated with 50 mg or 100 mg of ubrogepant who achieved freedom from pain within 2 hours of taking the medication was 19.2% and 21.2% respectively, versus 11.8% of patients who took a placebo (P = .0023, P = .0003). Of patients treated with 50 mg or 100 mg of ubrogepant, 38.6% and 37.7% had migraine behavioral symptom resolution respectively, versus 27.8% of patients who took a placebo (P = .0023, P = .0023). The adverse event profile of ubrogepant was similar to placebo and included nausea, somnolence, and dry mouth, all with less than 5% incidence.
Ubrogepant is a small molecule agonist of the calcitonin gene-related peptide receptor (CGRP) that is taken orally, in contrast to other CGRP-related treatments in development, which are given subcutaneously or via intravenous infusion.