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FDA Approves the First Drug of Its Kind to Treat Acute Migraines

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People dealing with painful migraines will soon have a new treatment available. This week, the U.S. Food and Drug Administration approved a unique drug meant to shorten acute migraine episodes. It’s the latest treatment for a condition that’s historically had few.

The drug is called Ubrelvy (compound name Ubrogepant), licensed by the pharmaceutical company Allergan. It works by blocking the effects of a protein called calcitonin gene-related peptide (CGRP), which has been shown to be important to triggering and sustaining migraines.

In 2018, the FDA approved the first specialized preventive treatment for migraines called Aimovig, which also works by blocking CRGP. But Ubrelvy is the first drug of its kind designed to treat migraines as they’re happening, according to the FDA. It’s also taken orally as opposed to Aimovig and similar drugs, which are taken through injection.

“Migraine is an often disabling condition that affects an estimated 37 million people in the U.S.,” said Billy Dunn, acting director of the Office of Neuroscience in the FDA’s Centre for Drug Evaluation and Research, in a statement. “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.”

The two largest clinical trials of Ubrelvy’s effectiveness involved nearly 1,500 people with a history of migraines, with or without the sensory symptoms that are called an aura. Compared to people given a placebo, those on Ubrelvy had a greater chance of any noticeable pain relief by the two-hour mark (61 percent vs. 49 percent), as well as a greater chance of feeling no pain at all by then. They were also more likely to experience relief from their most debilitating symptom that wasn’t pain, such as light sensitivity.

Meanwhile, reported side effects were mild and affected no more than 5 percent of patients. These included nausea, sleepiness, and dry mouth. That said, the drug isn’t recommended for people taking other medications that strongly inhibit an enzyme called cyp3a4—a list that includes several drugs that treat bacterial, viral, and fungal infections.

According to Allergen, Ubrelvy is expected to be available to customers in 50 or 100-milligram doses during the first quarter of 2020. At this point, there doesn’t appear to be an expected price for Ubrelvy made available, though Gizmodo has reached out to Allergen for comment. Aimovig’s list price, before taking into account insurance coverage and patient discounts, is $US6,900 ($9,936) annually.

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Schedule21 Mar 2023