The results from the phase 3 ACHIEVE I trial (NCT02828020) evaluated the efficacy, safety, and tolerability of ubrogepant (Allergan; Madison, NJ). Acute treatment of migraine with ubrogepant provided higher rates of pain freedom and freedom from the most bothersome migraine-associated symptom compared with treatement with placebo.
Ubrogepant (50 mg and 100 mg) showed statistically significant higher response rates for pain freedom at 2 hours (11.8% for placebo, 19.2% for 50 mg, 21.2% for 100 mg) and freedom from the most bothersome migraine associated symptom at 2 hours (27.8% for placebo, 38.6% for 50 mg, 37.7% for 100 mg). Both doses of ubrogepant at 50 mg and 100 mg demonstrated significant improvement compared with placebo for a secondary efficacy endpoint of pain relief at 2 hours (49.1% for placebo, 60.7% for 50mg, 61.4% for 100mg).
"The findings from the ACHIEVE I trial are particularly meaningful for primary care physicians who are first line in migraine management and need treatment options that are safe and effective to treat debilitating migraine symptoms," said Susan Hutchinson, MD, family practice headache specialist, founder of Orange County Migraine & Headache Center, and a paid consultant for Allergan. "With limited migraine-specific acute treatment options on the market, the approval of ubrogepant would provide healthcare providers and patients a much-needed new treatment option with a favorable side effect profile that can be taken on-demand to effectively treat a migraine attack."
Ubrogepant is a novel, highly potent, orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (-gepant).
In the trial, 1,672 adult participants, ages 18 to 75, with a history of migraine (with or without aura) were randomized (1:1:1) to placebo, ubrogepant 50 mg, or ubrogepant 100 mg. The study evaluated ubrogepant across a wide range of endpoints, including coprimary endpoints of pain freedom and freedom from the most bothersome of 3 nonheadache, migraine associated symptoms (no sensitivity to light, no sensitivity to sound, or no nausea) at 2 hours post initial dose.
Jakai D. Nolan, DO, MPH, and Jacqueline A. Nicholas, MD, MPH
Jill M. Giordano Farmer, DO
Danielle S. Shpiner, MD; Crystal Dixon, MD; Melissa R. Ortega, MD; and Henry Moore, MD