By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved Ubrelvy (ubrogepant) tablets for the immediate treatment of migraine with or without aura. In clinical trials, the drug eliminated migraine pain in about one of every five patients.

Ubrelvy is the first oral medication that blocks a protein released during migraine attacks — calcitonin gene-related peptide (CGRP) — from binding to receptors in the brain. The FDA has previously approved injectable CGRP inhibitors for migraine prevention.

“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 patients suffering from migraine and will continue to work with stakeholders to promote the development of new safe and effective migraine therapies,” said Billy Dunn, MD, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research.

Migraine affects about a billion people worldwide and 36 million adults in the United States, according to the American Migraine Foundation. It affects three times as many women as men. In addition to headache pain, migraine can also cause nausea, vomiting, blurriness or visual disturbances, and sensitivity to light and sound.

The effectiveness of Ubrelvy was demonstrated in two Phase 3 placebo-controlled trials involving 1,439 adult patients with a history of migraine with or without aura.

In one study, over 19% of patients said they were pain-free within two hours of taking Ubrelvy and nearly 39% were relieved of nausea and hypersensitivity to light and sound. That compares to 12% and 28% of patients, respectively, who were relieved of symptoms while taking a placebo.

Ubrelvy was effective for up to 24 hours. It is not approved as a preventive treatment of migraine.

"As someone living with migraine for 14 years, my life seems to be on pause when I experience a migraine attack," Kristin Molacek, a clinical trial patient, said in a press release from Allergan, which developed Ubrelvy.

"During the clinical trial, my experience with Ubrelvy was positive. It relieved the migraine symptoms that bothered me the most without serious side effects. We have needed this type of on-demand oral relief for a very long time, and I look forward to having the ability to better manage my migraine attacks."

Allergan said Ubrelvy will be available in the first quarter of 2020. Ubrelvy is non-narcotic and does not have addiction potential. It has been approved with two dose strengths, 50 mg and 100 mg. Allergan did not say how much the medication will cost.