Biohaven Nurtec™ ODT (rimegepant) launch in US market for migraine in adults

New Haven: Biohaven Pharmaceutical Holding Company has announced that NURTEC™ ODT (rimegepant) is now available by prescription in U.S. pharmacies. The U.S. Food and Drug Administration (FDA) approved NURTEC ODT for the acute treatment of migraine in adults on February 27, 2020. NURTEC ODT, which disperses almost instantly in a person's mouth without the need for water, works by blocking the CGRP receptor, treating a root cause of migraine. NURTEC ODT is not indicated for the preventive treatment of migraine.

BJ Jones, Chief Commercial Officer for Migraine and Common Diseases at Biohaven stated, "At Biohaven, helping those with migraine is personal to us. We understand the widespread and debilitating effects that patients experience. The urgency to provide new treatment options for the millions who live with it each day has underscored our efforts to bring NURTEC ODT to pharmacies quickly." Mr Jones added, "Biohaven is dedicated to minimizing barriers to medication access for people with migraine and has developed a suite of programs to help patients and physicians process access NURTEC ODT."

Treatment with NURTEC ODT is simple – a single dose of 75 mg provides fast pain relief, returns patients to normal function within one hour, and delivers sustained efficacy that lasts up to 48 hours for many patients, allowing people with migraine to get back to living their lives.

In order to ensure optimal patient access, Biohaven has developed a comprehensive, best-in-class suite of patient affordability and access programs. More information about NURTEC ODT and its patient support programs can be found at 1-833-4NURTEC, on the NURTEC ODT website and the NURTEC Twitter community.

Each eight-tablet pack of NURTEC ODT covers treatment of eight migraine attacks with one dose, as needed, up to once daily. Sample packs containing two tablets will also be made available to healthcare providers. Patients with migraine should discuss with their primary care provider or neurologist whether NURTEC ODT is appropriate for them.

NURTEC ODT is not opioid or narcotic, does not have addiction potential and is not scheduled as a controlled substance by the U.S. Drug and Enforcement Administration. The FDA approval of NURTEC ODT 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 pivotal Phase 3 trial, NURTEC ODT was generally well tolerated; the most common adverse reaction was nausea (2%) in patients who received NURTEC ODT compared to 0.4% of patients who received placebo. More information about the FDA approval is available here: https://www.biohavenpharma.com/investors/news-events/press-releases/02-27-2020.

NURTEC ODT is contraindicated in patients with a history of hypersensitivity to rimegepant, NURTEC ODT, or to any of its components. Hypersensitivity reactions with dyspnea and severe rash, including delayed serious hypersensitivity days after administration, occurred in less than 1% of subjects taking NURTEC ODT in clinical studies.

Read also: Biohaven Receives Fda Approval for acute migraine drug