The Lancet reveals that Remegis is safe and effective in preventing migraines

migraine is a chronic neurological disorder characterized by recurrent headaches, usually one-sided headaches, flared headaches, accompanied by fear of light, fear of sound, nausea and vomiting. More than 1 billion people worldwide suffer from migraines, three-quarters of whom are women. At present, migraine medication is generally divided into two categories - acute treatment and preventive treatment, acute treatment is used to relieve the symptoms of seizures, preventive medication reduces the frequency and severity of seizures. However, most traditional oral preventive treatments (e.g. β-blockers, anti-epileptic drugs and triceptic antidepressants) are not specifically developed for migraines and are generally less safe and resistant, as are clinically less patients.Recently, the Robert Croop team at Biohaven Pharmaceuticals in the United States published an article in The Lancet entitled "Oral Rimegepant for preventive treatment of migraine: a phase 2/3, randomized, double-blind, placebo-controlled trial" to study the effectiveness of oral remetrium in preventing migraines.Remegis is an oral calcitonin gene-related peptide (CGRP) peptide antagonist that has been approved in the United States for acute treatment of migraines in adults. In multiple randomized, placebo-controlled clinical trials, 75 mg doses of remegis were safe and effective. At present, four monoclonal antibodies targeting CGRP receptors or media have been identified as preventive treatment for migraines. The purpose of this study was to compare the safety, tolerance and effectiveness of taking remetrial and placebo every other day to prevent migraines.The team conducted a multicenter, randomized, double-blind, placebo-controlled trial at 92 research centers in the United States to assess the safety and effectiveness of remegis in migraine prevention treatment. The study consisted of three phases, including a four-week observation period, a 12-week double-blind treatment period, and subsequent follow-up period. Eligible participants, men and women 18 years of age and older, had a history of precursor migraines, no precursor migraines, or chronic migraines for at least one year, and had their first migraines before the age of 50. Participants must also have at least 4 (no more than 18) moderate or severe migraine episodes during the 3 months prior to the screening visit.Between November 14, 2018 and August 30, 2019, the team recruited 747 adults with at least one year's history of migraines. After a four-week observation period, participants were randomly assigned, of whom 373 were treated with remetrius and 374 were treated with matching placebos, one the next day for 12 weeks. The main end point of efficacy was a change in the average number of days of migraines per month in the last 4 weeks (9-12 weeks) compared to the 4 week observation period.In the end, a total of 695 participants were included in the efficacy analysis, including 348 in the Remegis group and 347 in the placebo group. For 9-12 weeks, the Remegis group outperformed the placebo group at the main endpoint of the change in the average number of migraine days per month. Compared to the observation period, the average number of migraine days per month decreased by 4.3 days in patients in the Remegis group and 3.5 days in the placebo group during the 9-12 weeks, with significant differences. 741 participants received the drug and were included in the safety analysis.Adverse events were reported in 133 (36%) out of 370 patients in the Remegis group and 133 (36%) out of 371 patients in the placebo group. There were 7 (2%) participants in the Remegis group, and 4 (1%) in the placebo group who discontinued the study due to adverse events, during which time no patients died. The results showed that taking Remegis the next day was effective in preventing migraines and was safe to bear.Current preclinical studies have shown that long-term antagonists of CGRP pathps are not associated with headaches caused by drug overuse. Therefore, the results of this study show the potential of Remegis in the preventive treatment of migraines. The use of Remegis in acute and preventive treatment of migraines may reduce the overall burden of migraine-related diseases. (Biological Exploration): Oral Rimegepant for the treatment of the treatment of the migraine: a phase 2/3, randomized, double-blind, placebo-controlled trial