Access to the PPM Journal and newsletters is FREE for clinicians.

Ubrogepant Shows Positive Results for Acute Treatment of Migraine; Gains FDA Approval

December 30, 2019
Phase 3 subjects achieved pain relief after two hours when compared to a placebo and other migraine treatments like triptans. FDA approval was granted at end-2019.

In the Pipeline (updated December 2019)

Migraine headaches are an extraordinarily common neurological disease, affecting 39 million people in the United States alone.1 More than four million migraine sufferers have chronic daily migraines, or at least 15 migraines per month.1 Yet, the disease is often under-diagnosed, leaving migraine sufferers without effective relief from the pain and related symptoms.

An oral CGRP receptor antagonist in Phase 3 testing by Allergan (Dublin) may soon offer a new treatment option for acute migraine pain. ACHIEVE I, the first of two Phase 3 clinical trials evaluating the efficacy, safety, and tolerability of ubrogepant, included 1,327 adult participants. Subjects either received 50 mg or 100 mg of ubrogepant or placebo to treat a single migraine attack of moderate or severe intensity.2

“There remains a need for new treatments with improved benefit-risk profiles,” said lead investigator Richard B. Lipton, MD, vice chair of neurology and director of the Montefiore Headache Center in a company release. “Results from this ubrogepant phase 3 trial are important in progressing the research and developing therapies to help migraine patients.”

Both the 50 mg and 100 mg doses had a statistically significant greater percentage of pain relief at two hours after the initial dose compared to placebo (50 mg vs placebo, P = 0.0023, 100 mg vs placebo, P = 0.0003). Both doses also demonstrated a statistically significant greater percentage in absence of the most bothersome migraine-associated symptom at two hours after the initial dose compared to placebo (50 mg vs placebo, P = 0.0023, 100 mg vs placebo, P = 0.0023).2

Adverse events of ubrogepant were comparable to placebo, with the most common being nausea, somnolence, and dry mouth, none of which were reported with a frequency of greater than 5%.2 Liver issues were minimal, with instances of high aminotransferase levels in participants being accompanied by alternative explanations, such as illness or medication, none of which were noted by the liver safety adjudication board as having a probable relationship to ubrogepant.2

“We are confident that ubrogepant will be an option for the treatment of migraines in adults,” said Allergan’s Chief Research & Development Office David Nicholson in a company release.

Update 4/30/18: Allergan has announced positive results from their second Phase 3 Trial (ACHIEVE II) on Ubrogepant. Click here to learn more.

Update 3/11/19: Allergan announced the FDA Acceptance of their NDA for Ubrogepant. A PDUFA date has been set by the FDA for Q4 2019. Click here to learn more.

Update 12/12/19: In late 2019, Allergan shared that its most recent Phase 3 studies of ubrogepant demonstrated “significantly greater rates of pain freedom at 2 hours with both the 50 mg and 25 mg doses” of the oral CGRP as well as reported “freedom from the most bothersome migraine-associated symptom at 2 hours with the 50 mg dose.” The company’s Achieve I and Achieve II trials were published in NEJM and JAMA respectively. FDA granted approval of the drug, branded UBRELVY, making it the first oral CGRP receptor agonist for acute treatment of migraine in adults with or without aura and the first FDA-approved gepant.


First published February 2018, with updates



Last updated on: December 30, 2019
Continue Reading:
Skin Patch Resolves Migraine Pain More Quickly with Fewer Side Effects
close X