Rimegepant new effective treatment of acute migraine, finds clinical Trial
Rimegepant (rimegepant Zydis) for the acute treatment of migraine, has returned positive results in phase 3 clinical trial. The drug at present is awaiting FDA approval.
Treatment of migraine attack with rimegepant was found to eliminate pain and other bothersome symptoms than placebo in a higher percentage of patients in a large scale trial reported in the New England Journal of Medicine. The clinical trial was led by researchers at Montefiore Health System and Albert Einstein College of Medicine.
Calcitonin gene-related peptide receptor has been implicated in the pathogenesis of migraine. Rimegepant is an orally administered, small-molecule, calcitonin gene-related peptide receptor antagonist.
Rimegepant belongs to a new generation of treatments for acute migraine headache. The drug is awaiting approval from the U.S. Food and Drug Administration and give benefits over migraine medicines presently available.
"For the first time in nearly three decades, people with migraine not helped by existing medications may have a new option to find relief during attacks," Richard B. Lipton, the study's first author and director of the Montefiore Headache Center, said in a press release.
Migraine is a chronic neurologic disorder that affects about 12 to 14% of people worldwide, It involves periodic attacks of head pain along with symptoms that may include nausea as well as sensitivity to light and sound. More than three-quarters of migraine sufferers experience at least one migraine attack per month, and more than half are severely impaired during their attacks.
Current migraine treatment involves triptan drugs that were introduced in the 1990s. The drugs act by stimulating serotonin receptors, which in turn reduces inflammation and constricts blood vessels, halting acute migraines. But in some people, triptans are known to produce intolerable side effects. Also, they are not recommended for people with cardiovascular disease or major CVD risk factors due to their action of vessels constriction.
Rimegepant that belong to the class of drugs called gepants which may be beneficial for such people. Gepants work by targeting the receptors for a small protein, called CGRP, long implicated in migraine. During migraine attacks, CGRP is released resulting in pain. Gepants relieve the pain and other symptoms of migraine by blocking the CGRP pathway.
The clinical trial assessed rimegepant, in a randomized double-blind trial involving more than 1,000 men and women with migraine at 49 centres in the U.S. The participants were instructed to take a tablet of rimegepant, or a matching placebo tablet, during a migraine attack, once moderate or severe pain developed. Before taking the tablet and for 48 hours afterwards, patients answered questions in an electronic diary concerning their pain and their most bothersome symptoms. Participants chose their most bothersome symptom from a list, including intolerance to light, intolerance to loud sounds, or nausea.
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Key findings of the trial include:
- Two hours after taking their tablets, 19.6% of patients in the rimegepant group were free from pain compared with 12.0% in the placebo group--a statistically significant difference.
- Freedom from their most bothersome symptoms occurred in 37.6% of patients in the rimegepant group and 25.2% in the placebo group.
- Side effects were minimal, with nausea and urinary tract infections the only adverse effects reported in more than 1% of patients in each group and no adverse CVD effects observed.
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"These results confirm that rimegepant's mechanism of action--blocking the CGRP pathway--effectively relieves pain and associated symptoms that occur during acute migraine attacks," said Dr. Lipton. "As someone who has studied CGRP blockers for more than a decade, I'm gratified to see their benefits confirmed in a large-scale clinical trial."