In nearly 1 in 4 U.S. households, someone suffers from migraine, according to the Migraine Research Foundation. And many of those affected haven’t found a medication that works. Now, there is a new migraine treatment option on the horizon. The FDA recently approved Ubrelvy (ubrogepant), a medication that acts quickly to help shorten the length of migraines.
What is migraine?
Migraine is not just a severe headache. In fact, migraine is counted as the sixth most disabling illness in the world. Aside from intense head pain, visual disturbances, nausea, vomiting, dizziness, extreme sensitivity to sound, light, touch and smell, and tingling or numbness in the extremities or face often accompany migraines.
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How common are migraines?
12% of the population—including 10% of children—experience migraines. They affect 18% of American women and 6% of men. In total, that’s more than 4 million people who have chronic daily migraine and experience more than 15 migraine days a month.
There are many prescription medications available to prevent migraine, and treat the symptoms once one starts. In addition, physicians sometimes recommend lifestyle changes (such as reducing stress or dimming the lights), urge patients to take over-the-counter or prescription strength NSAIDs (such as ibuprofen) to manage pain, prescribe antipsychotics, antidepressants, antiepileptic drugs, beta blockers, and even advise patients to receive Botox injections to reduce the frequency and symptoms of their migraines.
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What is Ubrelvy (ubrogepant)?
Ubrelvy (ubrogepant) is the latest treatment for migraines (with or without aura). It’s a novel treatment, meaning, it’s the first time this drug class is approved to treat migraines. That could be life-changing news for patients who haven’t experienced relief from existing drugs.
The FDA-approved medication is clinically proven to shorten the length of migraine episodes, as well as reduce the pain and symptoms associated with them. It works by blocking the effects of calcitonin gene–related peptide (CGRP) receptor. CGRP has been proven to be one internal component that triggers and sustains migraines. And although there are other drugs—injections by the name of Aimovig, Emgality, and Ajovy—that prevent migraines by blocking CGRP, Ubrelvy stands apart because it is an oral medication that works to cure migraines when they’re already happening. It comes with two dosing options (50 and 100 mg tablets) to provide flexibility for patients’ needs and to optimize effectiveness for the largest population.
Ubrelvy passed clinical trials and tests, which led to its final approval from the administration. According to the FDA, the medication’s effectiveness was demonstrated in two randomized, double-blind, placebo-controlled trials. During the studies, 1,439 adult patients with a history of migraine (with and without aura) received the approved doses of Ubrelvy to treat an ongoing migraine.
In both studies, approximately 19% of patients reported feeling no pain two hours after treatment (defined as a reduction in headache severity from moderate or severe pain to “no pain”) and 38.6% reported feeling complete relief from their most bothersome additional migraine symptom (nausea, light sensitivity, or sound sensitivity) two hours after treatment. These percentages are significantly higher among patients receiving Ubrelvy (at any dose) compared to those who received a placebo.
The most common side effects of Ubrelvy are nausea and somnolence (fatigue).
“As the first oral gepant, Ubrelvy offers a new and different type of acute treatment option for people living with the debilitating pain and other symptoms of migraine,” David Nicholson, executive vice president and chief R&D officer of Ubrelvy’s licensing company, Allergan, said in a press release. “Its oral administration with two dose strengths allows for treatment flexibility and relief when a migraine attack occurs. 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. At Allergan, we believe that migraine patients deserve access to all new medications for this debilitating disease.”
When will Ubrelby (ubrogepant) be available?
Allergan says that its new migraine treatment Ubrelvy will be available in the first quarter of 2020.