FDA Approves Novel Acute Migraine Treatment


Ubrogepant (Ubrelvy) is the first oral calcitonin gene-related peptide receptor antagonist approved by the FDA for the acute treatment of migraine.


Allergan’s ubrogepant (Ubrelvy) received FDA approval today for the treatment of migraine with or without aura in adults, according to an agency press release.1

Ubrogepant is a novel, highly potent, orally administered calcitonin gene-related peptide (CGRP) receptor antagonist and it is the first drug in this class to be approved for this indication. Ubrogepant is not approved for the preventive treatment of migraine, according to the FDA.1

The efficacy and safety of ubrogepant was demonstrated in the ACHIEVE I and ACHIEVE II clinical trials.2

In the studies, the safety, efficacy, and tolerability of ubrogepant 50 mg and 100 mg doses were compared with placebo for the acute treatment of a single migraine attack of moderate or severe headache pain intensity in 1671 adult patients.2

Pain freedom at 2 hours post initial dose:2

  • 50 mg ubrogepant: 19.2%

  • 100 mg ubrogepant: 21.2%

  • Placebo: 11.8%

Freedom from most bothersome migraine-associated symptom at 2 hours post initial dose:2

  • 50 mg ubrogepant: 38.6%

  • 100 mg ubrogepant: 37.7%

  • Placebo: 27.8%

Additionally, secondary efficacy endpoints for the studies included the clinical benefits of ubrogepant across various outcomes measures, such as pain relief at 2 hours, sustained pain relief from 2 to 24 hours, and sustained pain freedom from 2 to 24 ours, among others.2

Related: What Pharmacists Need to Know About Migraine

The most common adverse effects reported in the clinical trials were nausea, tiredness, and dry mouth. Ubrogepant is contraindicated for co-administration with strong CYP3A4 inhibitors.1

“Migraine is an often disabling condition that affects an estimated 37 million people in the US,” Billy Dunn, MD, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a statement.1 “Ubrelvy represents an important new option for the acute treatment of migraine in adults, as it is the first drug in its class approved for this indication. The FDA is pleased to approve a novel treatment for patient suffering from migraine and will continue to work with stakeholders to promote the development of new safe and effective migraine therapies.”



1. FDA approves new treatment for adults with migraine [news release]. FDA’s website. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-adults-migraine. Accessed December 23, 2019.
2. Dodick DW, Lipton RB, Ailani J, et al. Ubrogepant for the Treatment of Migraine. The New England Journal of Medicine. 2019. Doi: 10.1056/NEJMoa1813049

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