New migraine medicine! Nurtec ODT enters review in the U.S.: the first CGRP targeted drug to be proven to be effective in both acute and preventive treatments!

October 15, 2020 // -- Biohaven Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has accepted Nurtec ODT (Rimegepant, 75mg) application for a new supplement (sNDA) for preventive treatment of migraines.
the FDA has designated the SNDA's Prescription Drug User Charge Act (PDUFA) target date for the second quarter of 2021.
Urtec ODT was approved by the FDA in February for acute treatment of migraines (with or without precursor) in adults.
Nurtec ODT's active pharmaceutical ingredient, rimegepant, is a calcitonin gene-related peptide (CGRP) peptide antagonist that irreversibly blocks the CGRP subject, thereby inhibiting the biological activity of CRP neuropeptides.
CGRP and its subjects are expressed in areas of the nervous system associated with migraine pathophysiology.
CGRP-subject antagonist is a new mechanism of action for acute migraine therapy, which is significantly different from that of existing quentins (serotonin 1B / 1D astrists) and opioids.
, CGRP subjects have become a hot target for migraine drug development.
it's worth noting that Nurtec ODT is the first and only FDA-approved CGRP regulatory antagonist for the quick-acting oral disintegrative tablet (ODT) dosage form.
the drug can be immediately dispersed in the mouth without the need for water, can be very convenient, anytime, anywhere.
the launch of Nurtec ODT, which provides migraine sufferers with an important, new oral acute treatment that can quickly relieve and eliminate pain and restore life.
noted that Nurtec ODT has not been approved for preventive treatment for migraines.
In clinical studies, a single oral Nurtec ODT 75mg was able to quickly relieve pain and restore normal function within 1 hour, with continuous efficacy of up to 48 hours for many patients, and up to 86% of patients treated with single doses of Nurtec ODT did not use migraine rescue drugs within 24 hours.
Nurtec ODT has a novel, rapidly dissolved oral tablet form that treats the root cause of migraines by blocking the role of CGRP subjects.
Nurtec ODT is not an opioid or narcotic, is not addictive, and is not classified as a controlled drug by the U.S. Drug Enforcement Administration.
sNDA based on positive results from a randomized, placebo-controlled critical clinical trial (NCT03732638) published in March.
the trial was conducted in patients with seizure migraines (EM) and chronic migraines (CM) to assess the efficacy and safety of oral rimegepant 75mg preventive treatment of migraines.
results showed that the trial reached the main endpoint: at the third month of treatment, patients treated with oral rimegepant (n=348) had a statistically significant reduction in migraine days per month compared to placebo patients (n=347), compared to the baseline level (4.5 days vs 3.7 days, p=0.0176).
Among the study subjects who did not receive preventive treatment drugs at the same time, the Rimegepant treatment group (n=273) had 4.9 days less migraine days per month and the placebo group (n=269) had a 3.7-day reduction (nominal p=0.0020).
the study, 22 percent of the subjects received both preventive medications, including topiramate and amitriptyline.
, 48 percent of patients in the Rimegepant group had an average of 50 percent fewer moderate-severe migraine days per month than the baseline≥, compared with 41 percent in the placebo group.
, chief executive of Biohaven, said: "Migraine sufferers deserve simplified treatment with a drug to relieve acute seizures and prevent future seizures.
goal of our Nurtec ODT development project is to provide a quick-acting, instant oral tablet with "dual effects" for acute and preventive treatment of migraines.
We believe that the ease of use associated with a single oral drug will benefit migraine sufferers, enable them to be reborn, and provide a cost-effective approach to the health care system, rather than paying for two different drugs for acute and preventive treatment."
Robert Croop, Chief Development Officer, Biohave Neurology, said: "The widespread clinical activity of Nurtec ODT from acute to preventive may mark a paragraine treatment paranoia.
in our clinical trials, Nurtec ODT's therapeutic effectiveness and its good safety and tolerance suggest that the drug has the potential to be the best-in-class oral therapy for preventive treatment and acute migraine treatment.
In addition, in our preventive trials, Nurtec ODT's safety was consistent with its experience in acute treatment of adaptive disorders, and unlike other CGRP-targeted preventive drugs, Nurtec ODT as a preventive treatment did not show significant adverse reactions to constipation.
() Origin: U.S. FDA Accepts Biohaven's Supplemental New Drug Application (sNDA) Of NURTEC ™ ODT For The For The Treatment Of Migraine.