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Ubrelvy™ (ubrogepant) Approved by FDA for Acute Migraine Treatment

On December 23, 2019, the U.S. Food and Drug Administration (FDA) approved the use of Ubrelvy™ (ubrogepant) for the acute treatment of migraine, with or without aura. Ubrelvy™ is a gepant, or a calcitonin gene-related peptide (CGRP) receptor antagonist that is taken orally.

How does Ubrelvy™ work?

CGRP is a protein in the body, specifically in the brain and trigeminal system (sensory nerves of the head and neck). It is a signaling molecule of sorts. High levels of CGRP can be present during a migraine attack and impact pain signaling. New therapies have been developed to try to combat this, including gepants.

Gepants are small molecules that block the action of CGRP. Gepants like Ubrelvy™ can be taken orally and start acting on CGRP immediately. This allows for the acute treatment of migraine rather than long-term prevention.

Why is this an important approval for migraine?

Ubrelvy™ is the first gepant to receive FDA approval for the acute treatment of migraine. Other CGRP receptor antagonists have been approved in recent years for prevention of migraine, however, these are different from Ubrelvy™. Other previously approved CGRP-related drugs are monoclonal antibodies that are injected under the skin. Monoclonal antibodies are a type of biologic drug, or a drug made from living cells designed to target something very specific in the body (like CGRP). These other CGRP-related drugs are used as a preventative treatment option and have a long-lasting effect in the body.

Ubrelvy™ is different in that it is taken orally and is fast-acting. This means it can be used for the acute, immediate treatment of migraine. Ubrelvy™ has relatively mild side effects and does not have many limits on who can take it. This is different from another commonly used acute migraine treatment, sumatriptan.

Sumatriptan constricts blood vessels. People with cardiovascular risk factors or certain conditions may not be able to take sumatriptan. Sumatriptan can also cause undesirable side effects. More people may be able to use Ubrelvy™ for immediate relief with fewer side effects.

Ubrelvy™ in clinical trials

Ubrelvy™ was studied in two identically designed clinical trials called the ACHIEVE I and ACHIEVE II trials. Both were Phase III clinical trials that only differed in the dosage of Ubrelvy™ given. In each trial, roughly 1,500 people with migraine (with or without aura) participated and were split into three equal groups. In both studies, there was a placebo group (a control group that received a non-active drug). In the ACHIEVE I study, the other two groups received either 50 mg or 100 mg of Ubrelvy™. In the ACHIEVE II study, the other two groups received either 25 mg or 50 mg of Ubrelvy™.

In both studies, all doses of Ubrelvy™ were associated with higher rates of pain freedom at the 2-hour mark compared to placebo. Pain freedom is defined as being completely pain-free.

Each dose was also associated with a higher rate of freedom from the most bothersome migraine-related symptom 2 hours after taking the drug. Most bothersome symptoms included sensitivity to light, sensitivity to sound, and nausea.

In the ACHIEVE I study, both the 50 mg and 100 mg doses of Ubrelvy™ were associated with a significant improvement in pain relief compared to placebo. This means even if they weren’t completely pain-free, more people taking Ubrelvy™ found some level of pain relief than those given a placebo.

In addition to being effective, Ubrelvy™ was also found to have a favorable safety profile and to be well tolerated by those taking it. The side effect profile of Ubrelvy™ was similar to that of the placebo group.1-3

What are the side effects of Ubrelvy™?

The most common side effects of Ubrelvy™ include:

  • Nausea
  • Drowsiness
  • Dizziness
  • Dry mouth

Read the prescribing information to learn more about Ubrelvy™.

Ubrelvy™ is expected to be available in early 2020.

This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The Migraine.com team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.

  1. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-adults-migraine
  2. Dodick DW, Lipton RB, et al. Ubrogepant for the treatment of migraine. The New England Journal of Medicine. 5 Dec 2019; 381, 2230-41.
  3. Lipton RB, Dodick DW, et al. Effect of ubrogepant vs placebo on pain and the most bothersome associated symptom in the acute treatment of migraine: The ACHIEVE II randomized clinical trial. JAMA. 19 Nov 2019; 322(19), 1887-98.

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