The FDA’s latest decision is based on a clinical trial published in January 2021 in The Lancet. In this study, researchers found that when taken every other day, rimegepant effectively prevented migraine, resulting in fewer monthly migraine days compared with placebo (an inactive pill). “The FDA approval of Nurtec ODT for the preventive treatment of migraine — along with its acute treatment indication — is one of the most groundbreaking things to happen to migraine treatment in my 40 years of practicing headache medicine,” said Peter J. Goadsby, MD, PhD, in a press release. To have one medication patients can use to both treat and prevent migraines will likely change the treatment paradigm for patients going forward, added Dr. Goadsby, who was one of the researchers who studied Nurtec ODT in clinical trials. RELATED: 7 Strategies to Head Off Migraine Treatment Failure
What Is Nurtec? Key Facts About Anti-CGRP Treatments
Nurtec ODT (which stands for oral dissolving tablet) is a calcitonin gene-related peptide (CGRP) receptor antagonist. This type of drug targets the area of the brain to which the migraine-causing protein CGRP binds, according to the American Migraine Foundation. “By blocking the CGRP receptor, Nurtec ODT has been shown to both reduce pain and most bothersome symptoms during a migraine attack and provide a reduction in monthly migraine days,” says Goadsby, adding, “Nurtec ODT provides a more complete, flexible option that gives people with migraine increased control of their disease with considerable potential for individualized treatment.” Nurtec ODT is fast-acting and each dose can prevent or treat migraines for up to 48 hours, says its manufacturer, Biohaven Pharmaceuticals. CGRP-targeting drugs have had a significant impact on the treatment landscape for migraine, with the American Association of Medical Colleges calling their use “a new era for migraine relief.” Other migraine drugs that target the CGRP protein itself or the CGRP receptor include Emgality (galcanezumab), Ajovy (fremanezumab), Aimovig (erenumab), Ubrelvy (ubrogepant), and Vyepti (eptinezumab). Anti-CGRP treatments are generally well tolerated, states the American Migraine Foundation. In the most recent clinical trial for rimegepant, the most common side effects were nausea and stomach pain or indigestion. The manufacturer of Nurtec ODT warns against taking this drug if you:
Are allergic to it or any of its ingredientsHave liver or kidney issuesAre pregnant or planning to become pregnantAre breastfeeding or planning to breastfeed
RELATED: How Psychotherapy Can Help With Migraine
Who Gets Migraine? Recent Estimates Shed Light on Prevalence and Disparities
As of 2015, migraine affects an estimated 1 in 6 Americans, according to data published in March 2018 in the journal Headache. The prevalence is higher in women, affecting 20.7 percent of women (translating to 1 in 5 women) compared with approximately 9.7 percent of men (or 1 in 10 men), the study states. According to the researchers, groups that experience the highest burden of migraine or severe headache include:
American Indian or Alaska Native people (18.4 percent)People between ages 18 and 44 (17.9 percent)People who are unemployed (21.4 percent)People with a family income of less than $35,000 per year (19.9 percent)Elderly and disabled people (16.4 percent)
Headache is one of the most common reasons for a visit to the emergency room (ER), accounting for about 3 percent of ER trips per year, the authors of the study noted. Among women of reproductive age in particular, headache is the third leading cause of ER visits. Disparities in migraine treatment may be worsened if expensive treatments aren’t available to those who most need them, the study authors said. Newer migraine drugs like Nurtec ODT will almost certainly cost more than other migraine drugs that have been on the market longer and are available as low-cost generics.
