Freedom from Pain and Most Bothersome Symptoms of Migraine With Ubrogepant in Phase 3 Trial

Positive results were achieved in the phase 3 clinical trial that evaluated ubrogepant (Allergan; Madison, NJ) for acute treatment of migraine. The data is published in The Journal of the American Medical Association.   

For the 2 coprimary endpoints, ubrogepant 50 mg and 25 mg showed statistically significant higher response rates for pain freedom at 2 hours (21.8% for 50 mg, 20.7% for 25 mg, vs 14.3% for placebo) and the 50-mg dose showed statistically significant higher response rates for the freedom from the most bothersome migraine-associated symptom, photophobia, phonophobia, or nausea, at 2 hours (38.9% for 50 mg vs 27.4% for placebo). 

The ACHIEVE II trial (NCT02867709) was a multicenter, parallel-group study of ubrogepant (50 mg and 25 mg) that involved 1,355 adult participants 18 years of age to 75 years of age with a history of migraine, with or without aura. Participants were randomized (1:1:1) to placebo, ubrogepant 25 mg, or ubrogepant 50 mg. 

"Migraine is the second leading cause of disability, and we need new acute treatments that are efficacious, safe, and tolerable," said Richard B. Lipton, MD, professor and vice chair of neurology at the Albert Einstein College of Medicine and Montefiore Health System, and director of the Montefiore Headache Center. "Having ubrogepant as a potential new medication for the acute treatment of migraine will provide much-needed innovation for a disease that causes lost time for millions of people."