First Oral CGRP Blocker FDA-Approved for Migraine in Adults

Ubrogepant on-the-go tablets, 50 mg (top), 100 mg (bottom). Image courtesy of Allergan.

The US Food and Drug Administration (FDA) recently approved ubrogepant (Ubrelvy^™, Allergan) for the acute treatment of migraine with or without aura in adults. Ubrogepant is the first and only FDA-approved oral calcitonin gene-related peptide (CGRP) receptor antagonist to treat migraine once it starts.

In 2018, the FDA approved the first 3 injectable CGRP inhibitors for the prevention of migraine. Ubrogepant is for acute migraine management only.

“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,” said Billy Dunn, MD, acting director, Office of Neuroscience, Center for Drug Evaluation and Research, in an FDA press release. “The FDA is pleased to approve a novel treatment for patients suffering from migraine.”

Unlike some migraine treatments, ubrogepant works without constricting blood vessels and has no addiction potential. Ubrogepant blocks CGRP, a protein released during a migraine attack, from binding to its receptors.

Ubrogepant was approved in 2 dose strengths-50 mg and 100 mg-so physicians can provide patients a personalized treatment approach.

The effectiveness of ubrogepant for the acute treatment of migraine was demonstrated in 2 randomized, double-blind, placebo-controlled studies where >1400 adults with a history of migraine (with and without aura) received either the approved doses of ubrogepant or placebo.

In both studies, 50 mg and 100 mg doses of ubrogepant demonstrated significantly greater reductions in the co-primary endpoints of pain freedom and freedom from the most bothersome migraine symptoms (ie, nausea, light sensitivity) at 2 hours vs placebo.

Nausea was the most common adverse event, reported in 1.7%-4.1% of patients at various doses of ubrogepant vs 1.6%-2.0% of patients who received placebo. There were no serious adverse events reported within 48 hours of a dose.

“Its oral administration with two dose strengths allows for treatment flexibility and relief when a migraine attack occurs,” said David Nicholson, PhD, executive vice president, chief R&D officer, Allergan, in a company press release about the novel medication. “As we continue to drive innovation in migraine treatment, we are very proud to offer patients another option, and we are confident that it will make a difference for those in need.”

Migraine affects approximately 31 million Americans and is associated with significant disability, causing excess personal, familial, occupational, societal, and economic burden.  

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