FDA Approves New Migraine Drug for Faster Symptom Relief

An Oral dose of Ubrelvy diminishes incapacitating pain just within two hours, study finds.

The drug Ubrelvy will be available in the first quarter of 2020, according to manufacturer Allergan.

When a debilitating migraine hits, there is no “one dose-and-done” medicine that patients can rely on to get fast relief from this intense throbbing or pulsating headache.

Last week, the U.S. Food and Drug Administration (FDA) approved a new type of drug that will extend the options for acute (immediate) treatment of migraines, according to a press release.

Taken orally in a single tablet, Ubrelvy (ubrogepant) has been shown to terminate migraine pain and other related symptoms in adult patients with or without aura, a sensory phenomenon or visual disturbance that may accompany the condition.

“We are still searching for the perfect one-size-fits-all treatment, and medication is rarely, if ever, the whole treatment strategy,” says Robert Cowan, MD, professor of neurology and chief of the division of headache medicine at Stanford University in Palo Alto, California. “But this is a new arrow in our quiver and definitely merits a frank discussion with your provider.”

The drug will be available in the first quarter of 2020, according to a press release from Allergan, the pharmaceutical company that manufactures Ubrelvy. The company underscores that the drug is not for preventive therapy.

What Makes Ubrelvy Different

Around 12 percent of the U.S. population, or almost 40 million people (including children) suffer from this neurological disease, according to the Migraine Research Foundation. The recurring condition not only causes severe headache that can last between four hours and three days, but it can result to fatigue, nausea, and a sensitivity to light and noise.

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The National Headache Foundation estimates that about 1 in 5 patients have auras. These are visual symptoms, such as flashing lights, zigzag lines, or blind spots in sight.

Migraine sufferers currently have a variety of medicines to choose from that may bring some relief, the Mayo Clinic notes. These include over-the-counter aspirin and ibuprofen, as well as prescription drugs, such as sumatriptan (Imitrex, Tosymra), rizatriptan (Maxalt), and lasmiditan (Reyvow). There are also dihydroergotamines available as a nasal spray or injection.

Ubrelvy is a new type of calcitonin gene-related peptide (CGRP) inhibitor, according to the American Journal of Accountable Care. CGRP is a protein that can cause intense inflammation in the coverings of the brain (the meninges). Introduced in 2018, CGRP inhibitors include Aimovig (erenumab), Ajovy (fremanezumab), and Emgality (galcanezumab).

“CGRP starts very strong inflammatory reactions in the brain during many headache disorders; so by blocking CGRP, it is possible to reduce the pain transmission of headaches,” says Yili Huang DO, director of the Pain Management Center at Phelps Hospital in Sleepy Hollow, New York. “Until now, CGRP antagonists have only been available through injection, which can be uncomfortable and confusing to administer.”

Dr. Huang adds that so far these CGRP inhibitors are typically used as preventive treatment, meaning they can reduce the frequency, severity, and duration of attacks, but generally do not help relieve pain, disability, and progression of a headache once it has started.  

“Ubrelvy will be the first oral CGRP antagonist indicated for abortive treatment,” he says. “This gives patients another line of rescue treatment options to treat acute migraines.”

Promising Study Results

The FDA greenlighted the drug after a study published in November 2019 in the Journal of the American Medical Association documented that about 20 percent of 1,465 participants taking 25 milligrams of Ubrelvy felt pain-free after two hours, and 34 percent were relieved of most bothersome symptoms, such as light and noise sensitivity. A higher dose yielded these results for 22 percent and 39 percent of participants, respectively.

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In comparison, about 12 percent of those taking a placebo were free from pain after two hours and about 28 percent got rid of their bothersome symptoms.

The most common side effects were nausea, dizziness, and dry mouth.

An Alternative to Available Therapies

“Patients with migraine often note dissatisfaction with current medication due to lack of efficacy, partial benefit on migraine, recurrence of pain, lack of consistency of response, and intolerable side effects,” says Noah Rosen, MD, director of Northwell Health’s Headache Center in Great Neck, New York. “A more specific treatment like Ubrelvy is likely to be provide a better option for patients on all of these areas than what is commonly used.”

Dr. Rosen and other doctors point out that some migraine drugs, such as triptans, constrict blood vessels, making them a higher risk for patients with cardiovascular disease.

“There is no strong current evidence that CGRP antagonists cause significant blood vessel narrowing, so they may be potentially safer for these patients,” says Huang.

For Dr. Cowan, a drug that works in the CGRP pathway is “important because it represents a true alternative to triptans in patients for whom triptans are either ineffective or not tolerated.”

The study authors noted that further research is still needed to assess the effectiveness of Ubrelvy against other acute treatments for migraine and to evaluate its long-term safety.

Another oral CGRP inhibitor called rimegepant (from Biohaven Pharmaceuticals) showed similarly promising results and is currently awaiting FDA approval, according to an article published July 2019 on BioSpace.

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