Fast-acting rimegepant for acute migraine

April 4, 2020 0 By FM

The US FDA has approved rimegepant (Nurtec ODT 75 mg) for the acute treatment of migraine in adults.

A single oral dose of the drug can provide fast pain relief and deliver sustained efficacy that lasts up to 48 hours for many patients, said Biohaven.

Rimegepant is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a quick-dissolve ODT formulation that is approved by the FDA for the acute treatment of migraine in adults. 

The drug disperses almost instantly in a person’s mouth without the need for water.

Rimegepant works by blocking CGRP receptors. It is not scheduled as a controlled substance by the US Drug Enforcement Administration.

The FDA approval of the drug is based on results from the pivotal phase 3 clinical trial (Study 303) and the long-term, open-label safety study (Study 201). 

In the phase 3 trial, it achieved statistical significance on the regulatory co-primary endpoints of pain freedom and 3/4/2020 FDA approves fast-acting rimegepant for treating acute migraine in adults.