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FDA approves first dual-treatment migraine medication, ‘paradigm shift’ in migraine management

According to the company, taking the medication every other day for a week decreased migraine days by 30%, and nearly half of the participants reported a 50% reduction in moderate-to-severe migraine days after three months. The drug works by blocking a receptor that has been linked to migraines.

Lilly Rockwell’s earliest childhood recollections are marred by terrible migraines that caused her to vomit. Her migraine illness deteriorated as she grew older, and she concerned about how it might affect her work and personal life.

Rockwell, 37, of Austin, Texas, enrolled with her mother in a clinical trial for Biohaven’s Nurtec ODT (rimegepant), a migraine-prevention drug. On May 27, the dissolvable pill received wider FDA approval as an acute and preventative migraine therapy for the first time.

The results of Biohaven’s late-stage trial of rimegepant, a calcitonin gene-related peptide receptor antagonist, were published in The Lancet, and according to the company, the drug reduced migraine days by 30% after a week when taken every other day, and about half of participants experienced a 50% reduction in moderate-to-severe migraine days after three months. The medication acts by inhibiting a receptor that is linked to migraines.

For Rockwell, she reports altogether more headache free days.

“I was able to focus more time and energy on my career helping people find their dream homes and my social life,” she wrote in an email. “I could enjoy more of the little things in life, and I felt for the first time what it’s like to live as a person who doesn’t get migraines.”

Patients with less than 15 migraine days per month can now get the medication. According to the FDA, the most frequent adverse effects are nausea, stomach discomfort, and indigestion, which happened in around 2% of trial participants, while significant side effects include allergic reactions, breathing difficulties, and dermatitis.

According to numerous experts, the drug’s clearance will “significantly impact the way” the medical community thinks about and treats migraines.

“In the past, treatments were considered as either abortive — taken after a migraine begins, or preventive — taken at a regular cadence to prevent a migraine,” Dr. Zubair Ahmed, a neurologist and headache specialist with Cleveland Clinic who was not involved with Biohaven or rimegepant, said. “However, the indication for rimegepant as a rescue and preventive shifts this paradigm of treatment.” 

Rockwell, 37 of Austin, Texas, was a participant in a clinical trial for Biohaven’s Nurtec ODT (rimegepant) as a preventive migraine treatment. 
Rockwell, 37, of Austin, Texas, took part in a research trial for Biohaven’s Nurtec ODT (rimegepant), a migraine prevention drug. (Photo credit: Biohaven)

The approval “resulted in a paradigm shift in the management of this disease,” according to Vlad Coric, MD, and CEO of Biohaven Pharmaceuticals. “This means that for the first time, one medication therapy can be used to both treat migraines as they occur and prevent the next one.”

Other migraine medications, according to Dr. Richard Lipton, director of the Montefiore Headache Center, who was involved in the drug’s development and clinical trials, may cause more headaches after frequent use, a phenomenon known as medication-overuse headache, whereas rimegepant was said to have the opposite effect.

“Migraines can be severely debilitating and are considered one of the main causes of disability worldwide,” according to the Centers for Disease Control and Prevention (CDC),” with “15.3% of Americans aged 18 years or older reporting a migraine or severe headache in the previous 3 months, a figure that has remained stable for almost two decades.”

Nonetheless, despite this landmark moment, some of the barriers to patient access are likely to continue. It’s a “costly treatment available primarily for patients with commercial insurances,” according to Ahmed.

According to a statement from Biohaven, the company is working to gain coverage for preventive use, despite the fact that 67% of Medicare and Medicaid insured patients (over 78 million people) have access to acute care, with 89% of commercially insured patients (over 150 million people) having broader coverage.

Furthermore, Eli Lilly recently announced the start of a head-to-head study comparing Emgality (galcanezumab-gnlm) with Nurtec ODT (rimegepant) for migraine prevention. While Emgality is thought to attach to a protein involved in migraine onset, Nurtec is said to inhibit the receptor.

“This study aims to answer important questions that will help clinicians and patients make more informed treatment decisions on the path to more migraine-free days,” Lilly wrote in a company announcement.

The news prompted a reactionary response from Biohaven’s Vlad Coric, Director and CEO.

“Nurtec ODT is clearly establishing itself as the leading migraine therapy with a profile that others want to aspire to,” Coric wrote in part, in an emailed statement. “In our opinion, this study by Lilly is a competitive move by a company with an injectable drug to try to hold market share despite shifting sentiment to oral CGRP targeting drugs now being approved for the prevention of migraines.”

The results of Biohaven’s late-stage trial of rimegepant were published in The Lancet on January 2nd, 2021. The drug gained expanded FDA approval on May 27th, 2021.

Findings. Between Nov 14, 2018, and Aug 30, 2019, 1591 participants were recruited and assessed for eligibility, of whom 747 were randomly allocated either rimegepant (n=373) or placebo (n=374). 695 participants were included in the analysis for efficacy, of whom 348 were assigned rimegepant and 347 were allocated placebo. Rimegepant was superior to placebo on the primary endpoint of change in the mean number of migraine days per month during weeks 9–12. The change from the observation period in mean number of migraine days per month during weeks 9–12 was −4·3 days (95% CI –4·8 to –3·9) with rimegepant and −3·5 days (–4·0 to –3·0) with placebo (least squares mean difference −0·8 days, 95% CI −1·46 to −0·20; p=0·0099). 741 participants received study medication and were included in the safety analysis. 133 (36%) of 370 patients who received rimegepant reported an adverse event, compared with 133 (36%) of 371 who received placebo. Seven (2%) participants who received rimegepant and four (1%) who received placebo discontinued the study due to an adverse event; no patients died.

Interpretation. Taken every other day, rimegepant was effective for preventive treatment of migraine. Tolerability was similar to that of placebo, and no unexpected or serious safety issues were noted.

Croop R, Lipton RB, Kudrow D, Stock DA, Kamen L, Conway CM, Stock EG, Coric V, Goadsby PJ. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet. 2021 Jan 2;397(10268):51-60. doi: 10.1016/S0140-6736(20)32544-7. Epub 2020 Dec 15. PMID: 33338437.

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