Small molecule antagonists for migraine-prevention CGRP subjects are expected to be approved next year

Migraine is a debilitating neurological disease that is the third largest disease in the world and the seventh largest cause of disability in the world.
It is a disabling and recurrent disease that can last up to 4 to 72 hours and is accompanied by a variety of symptoms, including throbbing, moderate-to-severe pain intensity of one-sided headaches, nausea and/or vomiting, fear of light and fear of sound.
Nurtec ODT, the first CGRP-subject antagonist with a rapidly dissolving agent, has been approved by the FDA for acute treatment of migraines in adults.
neuropeptide CGRP is thought to play a causal role in the pathophysiology of migraines.
Nurtec blocks CGRP subjects by reversible, inhibiting the biological activity of CGRP neuropeptides.
sNDA application is based on a critical migraine prevention trial for migraine patients (Study 305) and a long-term, open label safety study (Study 201) that supports the approval of Nurtec for acute migraine treatment.
study 305 reached its primary endpoint, and in the third month of treatment, compared to placebo, the number of migraine days per month in the group treated with Nurtec was significantly lower than the baseline statistics, and the number of migraine attacks per month in patients (n-348) was reduced by 4.3 days compared to the baseline, while the placebo group was reduced by 3.5 days (n-347;p-lt;0.05).
importantly, the average number of days of moderate to severe migraines per month was reduced by at least 50 percent compared to the baseline in 49.1 percent of patients in the Nurtec group, compared with 41.5 percent in the placebo group.
: U.S. FDA Accepts Biohaven's Supplemental New Drug Application (sNDA) Of NURTEC™ ODT For The Minute Treatment Of Migraine. Retrieved October 14, 2020, from