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▎ WuXi AppTec content team editor May 27, 2021, Biohaven Pharmaceuticals announced that the US FDA has approved its small molecule CGRP receptor inhibitor Nurtec oral disintegrating tablets (rimegepant 75 mg) for extended indications for paroxysmal migraine Preventive treatment (less than 15 migraine attacks per month).
The press release states that Nurtec is the first oral CGRP receptor inhibitor approved for the preventive treatment of migraine and the only migraine drug approved for both acute treatment of migraine attacks and preventive treatment.
This approval makes it expected to benefit close to 95% of migraine sufferers.
The FDA approval is based on a randomized, double-blind, placebo-controlled Phase 3 clinical trial.
The main endpoint of the trial showed that Nurtec performed significantly better than placebo, and the number of migraine days per month was reduced by 4.
3 days after 3 months of treatment.
The preventive effect of Nurtec was observed as early as the first week of treatment, and the number of migraine days was reduced by 30%.
In addition, a key secondary endpoint showed that about half of patients treated with Nurtec reduced the number of days of moderate to severe migraine each month by more than 50%.
In addition, Nurtec is generally well tolerated, with the most common side effects being nausea (2.
7% vs.
0.
8% in the placebo group) and stomach pain/dyspepsia (2.
4% vs.
0.
8% in the placebo group).
Patients who have a history of allergies to rimegepant and any of its ingredients should not use Nurtec.
Small molecule CGRP receptor inhibitors represent a new class of drugs for the treatment of migraine, and the activity of CGRP is thought to cause migraine pathologically.
With its new fast-dissolving tablet formulation, Nurtec works by blocking CGRP receptors.
Through this targeted mechanism of action, a single administration of Nurtec can quickly relieve the pain of many patients, and the effect lasts for 48 hours.
Nurtec can be taken once a day as needed to stop attacks, or once every other day to help prevent migraines and reduce the number of migraine days per month.
Migraine is the disease with the third highest incidence in the world.
Hundreds of millions of people suffer from migraine in the world.
The World Health Organization (WHO) lists migraine as the 10 most disabling medical illnesses (disabling medical illnesses).
one.
Its typical feature is intermittent attacks lasting 4 to 72 hours, and may cause nausea, vomiting, phonophobia, photophobia, moderate to severe pulsatile headache.
According to a new survey, 84% of patients currently receiving preventive treatment want better treatment options, 53% want fewer days of attacks, and 67% report that the number of migraine attacks has increased their For depression and anxiety, almost all respondents (98%) said they are willing to consider new oral medications.
"The US FDA's approval marks the beginning of a new era in migraine treatment, allowing the use of a single drug to treat and prevent migraine attacks in patients at the same time.
Nurtec's pioneering therapy can help reduce the complexity of treatment options and reduce treatment compliance.
And the challenges of multiple medications have a significant impact on the lives of patients.
" said Dr.
Vlad Coric, CEO of Biohaven.
Reference: [1] FDA Approves Biohaven's NURTEC® ODT (rimegepant) for Prevention: Now the First and Only Migraine Medication for both Acute and Preventive Treatment.
Retrieved May 27, 2021, from https:// -releases/fda-approves-biohavens-nurtec-odt-rimegepant-for-prevention-now-the-first-and-only-migraine-medication-for-both-acute-and-preventive-treatment-301301304.
htmlNote: This article aims to introduce the progress of medical and health research, not to recommend treatment options.
If you need guidance on the treatment plan, please go to a regular hospital for treatment.