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Two Medications Approved for Migraine Treatment: Clinical Trial Results Summary – Ubrogepant and Lasmiditan

Approximately 31 million Americans suffer from migraines, a neurological disease characterized by intermittent attacks that can cause such severe pain as to be debilitating. It is the second leading cause of disability worldwide and the third most common disease.

Researchers diligently work to find a cure. Meanwhile, the U.S. Food and Drug Administration (FDA) has recently approved two new drugs for the acute treatment of migraine. Neither drug provides a cure for migraine, but they both offer relief from the pain once it begins. Neither drug has any indication for use as a preventive treatment.

Ubrogepant

In December 2019, the FDA approved Ubrogepant, sold under the trade name Ubrelvy™ by Allergan, for the acute treatment of migraine headaches whether the headache begins with or without an aura. The approval was based on four clinical studies which established the safety and efficacy of the medication.

The clinical studies found the medication relieved the migraine pain within about two hours after the medication is taken. The uncomfortable side effects of migraine, such as nausea and hypersensitivity to light and sound, were also relieved by Ubrogepant.

The medication is believed to work by blocking the calcitonin gene-related peptide (CGRP), a protein that is released in the bloodstream during a migraine attack, from binding to its receptors. It does not cause the blood vessels to constrict as some older medications do.

Ubrogepant is non-narcotic and is not classified as a government controlled substance. It has no addiction potential and has been approved for 50 mg or 100 mg dosages.

The clinical trials show there were no serious adverse events within 48 hours of the first dose of the medication. The most common side-effects include nausea, dry mouth, and somnolence (drowsiness, strong desire for sleep).

Rimegepant

In Febrary 2020, the FDA approved Rimegepant, sold under the name Nurtec ODT by Biohaven, … [this medication is extremely similar to ubrogepant in how it works].

Lasmiditan

In October 2019, the FDA approved lasmiditan sold by Eli Lilly and Company under the brand name Reyvow. It is approved for an acute treatment of migraine whether the headache begins with an aura or not. Clinical studies show a significant number of patients who took the medication at the first sign of a migraine stopped the development of a full-blown migraine within two hours of the dose. Most patients were then able to return to their normal activity.

The main side effects were fatigue, dizziness, sleepiness, and paresthesia (tingling or prickling sensation to the peripheral nerves). Because of these side effects, patients are advised not to drive within eight hours of taking the dose or do any activities that require mental alertness. Alcohol should be used with caution by those who take lasmiditan. Lasmiditan is listed as a controlled substance due its potential for abuse.

Lasmiditan works on a specific type of serotonin receptor found on nerves that are responsible for transmitting the pain of a headache. The clinical studies indicate that lasmiditan blocks the migraine without having any effect on the blood vessels.

At the Will Erwin Headache Research Center, we are dedicated to the study of debilitating headaches of all kinds. Our goal is to bring relief to headache sufferers around the globe by funding research that focuses on finding a cure. We always accept donations that will help fund our research.