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# Biohaven Pharma Migraine Drug Approved
- URL: https://www.fdaweb.com/biohaven-pharma-migraine-drug-approved/
- Published: 2020-03-02T12:00:00.000Z
- Updated: 2026-09-14T16:05:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146216

FDA has approved a Biohaven Pharmaceutical Holding NDA for Nurtec ODT (rimegepant) for the acute treatment of migraine in adults. The quick dissolving product is intended to provide pain relief and return patients to normal function within one hour, the company says. The drug is not indicated for preventing migraines, it says.

Approval is based on data from a Phase 3 clinical trial (Study 303) and a long-term, open-label safety study (Study 201). Data showed that the drug “achieved statistical significance on the regulatory co-primary endpoints of pain freedom and freedom from most bothersome symptom (MBS) at two hours post dose compared to placebo,” the company says. It says it also demonstrated statistical superiority at one hour for pain relief (reduction of moderate or severe pain to no pain or mild pain) and return to normal function.

Rimegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist that works by reversibly blocking CGRP receptors, thereby inhibiting the biologic activity of the CGRP neuropeptide, Biohaven says. This mode of action offers an alternative to current agents, such as triptans, it adds.