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Recently, the US FDA announced the approval of an oral CGRP inhibitor Nurtec ODT (Rimegepant, 75mg) as an extended indication for the preventive treatment of paroxysmal migraine.
▌Migraine attacks frequently, and the patient is miserable
▌Migraine attacks frequently, and the patient is miserable
Migraine is the third most popular disease in the world and the seventh leading cause of disability in the world.
It is estimated that the total number of migraine sufferers in the world exceeds 1 billion, mainly in young and middle-aged people, and the incidence rate of women is higher than that of men.
It is estimated that the total number of migraine sufferers in the world exceeds 1 billion, mainly in young and middle-aged people, and the incidence rate of women is higher than that of men.
People who have never experienced the pain of migraine can't imagine it.
The attack time can last 4-72 hours, and is accompanied by a variety of symptoms, usually including: pulsating, moderate to severe pain intensity unilateral headache, may be accompanied by nausea and/or vomiting, sensitivity to light and sound (photophobia and photophobia) Sound), it may happen suddenly without warning.
The attack time can last 4-72 hours, and is accompanied by a variety of symptoms, usually including: pulsating, moderate to severe pain intensity unilateral headache, may be accompanied by nausea and/or vomiting, sensitivity to light and sound (photophobia and photophobia) Sound), it may happen suddenly without warning.
Some people say that migraine is not a serious illness, but it is really "life-threatening" when it hurts.
About 90% of migraine patients are unable to work or live normally during the attack.
For patients who often suffer from migraine headaches, a convenient, quick relief of symptoms and a preventive treatment that reduces the number of attacks will be a great boon.
For patients who often suffer from migraine headaches, a convenient, quick relief of symptoms and a preventive treatment that reduces the number of attacks will be a great boon.
According to a survey on preventing migraine attacks:
Among the patients currently receiving preventive treatment, 84% want better treatment options.
53% of people want fewer days of attacks, and 67% said that as the number of migraine attacks increases, their risk of anxiety and depression will increase.
Almost all respondents (98%) indicated that they would consider a new oral treatment.
53% of people want fewer days of attacks, and 67% said that as the number of migraine attacks increases, their risk of anxiety and depression will increase.
Almost all respondents (98%) indicated that they would consider a new oral treatment.
▌Oral CGRP receptor inhibitor: Nurtec ODT
▌Oral CGRP receptor inhibitor: Nurtec ODT
Nurtec is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist in an orally disintegrating tablet (ODT) formulation.
Previously, the drug has been approved by the FDA for the acute treatment of migraine.
Previously, the drug has been approved by the FDA for the acute treatment of migraine.
As a CGRP receptor antagonist, Nurtec inhibits the biological activity of CGRP neuropeptide by reversibly blocking the CGRP receptor.
The recommended dose of Nurtec ODT is 75 mg, and a single dose can provide many patients with rapid pain relief that lasts up to 48 hours.
Patients can take it once a day as needed to stop migraine attacks; or take it every other day to help prevent migraine attacks and reduce the number of migraine days per month.
Patients can take it once a day as needed to stop migraine attacks; or take it every other day to help prevent migraine attacks and reduce the number of migraine days per month.
It should be noted that avoid simultaneous administration of Nurtec ODT with strong CYP3A4 inhibitors, moderate CYP3A inducers, or BCRP inhibitors.
When administered with a moderate CYP3A4 inhibitor, avoid taking Nurtec ODT again within 48 hours.
When administered with a moderate CYP3A4 inhibitor, avoid taking Nurtec ODT again within 48 hours.
▌The number of migraine days has decreased, and the clinical trial has reached the primary endpoint!
▌The number of migraine days has decreased, and the clinical trial has reached the primary endpoint!
The FDA’s approval is based on positive data from a double-blind, randomized, open-label, placebo-controlled Phase 3 clinical trial.
The main study endpoint results show that:
· The Nurtec treatment group was significantly better than the placebo group.
After three months of treatment, the number of migraine days per month was reduced by 4.
3 days.
As early as the first week of treatment, Nurtec's preventive effect was observed, and the number of migraine days was reduced by 30%.
After three months of treatment, the number of migraine days per month was reduced by 4.
3 days.
As early as the first week of treatment, Nurtec's preventive effect was observed, and the number of migraine days was reduced by 30%.
In addition, a key secondary endpoint showed that after 3 months of treatment, about half of patients had a 50% or more reduction in the number of days of moderate to severe migraine per month.
And, the drug is well tolerated.
And, the drug is well tolerated.
Reference materials:
Reference materials:
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