NEW HAVEN, Conn., Dec. 16, 2020 /PRNewswire/ --- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced today that The Lancet published the company's positive results from a Phase 3 clinical trial of rimegepant for the preventive treatment of migraine in adults. These data show rimegepant was superior to placebo in the reduction of monthly migraine days. Rimegepant was approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine in February 2020. Rimegepant is marketed as NURTEC® ODT, and is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in an orally disintegrating tablet (ODT) designed for rapid onset of action.
Peter J. Goadsby, M.D., Ph.D., D.Sc., study co-author, Professor of Neurology at King's College, London and the University of California, Los Angeles, commented, "These data demonstrate the continued innovation in migraine treatment aimed at CGRP mechanisms. This is the first time an oral CGRP migraine treatment has shown dual efficacy in both the acute and preventive treatment of migraine. With this flexibility, these therapies are truly disruptive and change the treatment paradigm for people living with migraine."
In the Phase 3 double-blind, randomized, placebo-controlled trial, 747 people with migraine were randomized. Rimegepant was superior to placebo on the primary endpoint of change in mean number of migraine days per month during Weeks 9-12. Rimegepant showed a −4.3 day reduction in monthly migraine days during the prespecified treatment period. Notably, the positive response to rimegepant was seen during the first four weeks of treatment and suggests an early onset of preventive effects.
Richard B. Lipton, M.D., study co-author, Professor and Vice Chair of Neurology at the Albert Einstein College of Medicine and Montefiore Health System, Director of the Montefiore Headache Center, stated, "Migraine is a prevalent and debilitating disease, affecting roughly 1 in 6 Americans, and many are not helped by current treatments. The results published in The Lancet demonstrate the significant clinical benefits of rimegepant for the preventive treatment of migraine. These data show the promise of a new approach to preventive treatment with an oral CGRP antagonist."
Rimegepant was also superior to placebo on multiple secondary endpoints. Notably, 49% of the rimegepant group had at least a 50% reduction from baseline in mean number of moderate to severe migraine days per month compared to 41% in the placebo group in weeks 9 through 12. Additionally, the incidence of adverse events was similar with rimegepant and placebo (36% vs 36%).
Vlad Coric, M.D., Chief Executive Officer of Biohaven, commented, "We are extremely excited by the publication of the rimegepant prevention of migraine data in TheLancet, one of the most influential scientific journals in medicine. For several years, leaders in the field such as Drs. Lipton and Goadsby hypothesized that CGRP antagonists could be effective as both an acute and preventive migraine therapy. The results of our pivotal prevention study show that "dual acting" efficacy — acute and preventive —can be achieved in a single CGRP targeting drug such as rimegepant."
This is the fourth pivotal randomized placebo-controlled clinical trial that demonstrated the efficacy and safety of rimegepant in migraine. Nurtec ODT (rimegepant) is currently approved by the FDA for the acute treatment of migraine in adults. The FDA accepted Biohaven's supplemental New Drug Application (sNDA) for NURTEC ODT for the preventive treatment of migraine in October 2020 and the Prescription Drug User Fee Act (PDUFA) goal date is in 2Q2021.
Dr. Coric added, "Our strategic goal with the rimegepant development program is to offer patients a fast acting, quick-dissolve oral tablet with 'dual-acting' properties to treat migraine across the full spectrum from acute to preventive treatment. This publication in The Lancet demonstrates that rimegepant has the potential to prevent migraine in addition to its previously established efficacy in the acute treatment of migraine. People with migraine deserve a simple to use, single oral medication that can help them take back their days when a migraine strikes and also prevent future attacks."
The Lancet full article is available online. Drs. Lipton and Goadsby have served as consultants to Biohaven and their full disclosures are listed in the referenced publication.
About Nurtec ODT
NURTEC® ODT (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 U.S. Food and Drug Administration (FDA) for the acute treatment of migraine in adults. The activity of the neuropeptide CGRP is thought to play a causal role in migraine pathophysiology. NURTEC ODT is a CGRP receptor antagonist that works by reversibly blocking CGRP receptors, thereby inhibiting the biologic activity of the CGRP neuropeptide. The recommended dose of NURTEC ODT is 75 mg, taken as needed, up to once daily. The safety of treating up to 15 migraines in a 30-day period has been established. For more information about NURTEC ODT, visit www.nurtec.com.
About CGRP Receptor Antagonism Small molecule CGRP receptor antagonists represent a novel class of drugs for the treatment of migraine. This unique mode of action potentially offers an alternative to current agents, particularly for patients who have contraindications to the use of triptans, or who have a poor response to triptans or are intolerant to them.
Indication NURTEC ODT is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use NURTEC ODT is not indicated for the preventive treatment of migraine.
Important Safety Information Contraindications: Hypersensitivity to NURTEC ODT or any of its components.
Warnings and Precautions: If a serious hypersensitivity reaction occurs, discontinue NURTEC ODT and initiate appropriate therapy. Serious hypersensitivity reactions have included dyspnea and rash, and can occur days after administration.
Adverse Reactions: The most common adverse reaction was nausea (2% in patients who received NURTEC ODT compared to 0.4% in patients who received placebo). Hypersensitivity, including dyspnea and rash, occurred in less than 1% of patients treated with NURTEC ODT.
Drug Interactions: Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4, strong or moderate inducers of CYP3A or inhibitors of P-gp or BCRP. Avoid another dose of NURTEC ODT within 48 hours when it is administered with moderate inhibitors of CYP3A4.
Use in Specific Populations:
Pregnant/breast feeding: It is not known if NURTEC ODT can harm an unborn baby or if it passes into breast milk.
Hepatic impairment: Avoid use of NURTEC ODT in persons with severe hepatic impairment.
Renal impairment: Avoid use in patients with end-stage renal disease.
About Biohaven Biohaven is a commercial-stage biopharmaceutical company with a portfolio of innovative, best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases, including rare disorders. Biohaven's neuroinnovation portfolio includes FDA-approved NURTEC™ ODT (rimegepant) for the acute treatment of migraine and a broad pipeline of late-stage product candidates across three distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine; glutamate modulation for obsessive-compulsive disorder, Alzheimer's disease, and spinocerebellar ataxia; and myeloperoxidase (MPO) inhibition for multiple system atrophy and amyotrophic lateral sclerosis. More information about Biohaven is available at www.biohavenpharma.com.
Forward-Looking Statements This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Company's management. All statements, other than statements of historical facts, included in this press release regarding the Company's business and product candidate plans and objectives are forward-looking statements. Forward-looking statements include those related to: commercialization and sales of NURTEC ODT and the potential approval and commercialization of other product candidates, the effect of the ongoing COVID-19 pandemic on Biohaven, the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials, the timing of planned interactions and filings with the FDA, the timing and outcome of expected regulatory filings, including the need for any REMS or Advisory Committee meetings, the potential for Biohaven's product candidates to be first in class or best in class therapies and the effectiveness and safety of Biohaven's product candidates. The use of certain words, including "believe", "continue", "may", "on track", "expects" and "will" and similar expressions, are intended to identify forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of Biohaven's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 26, 2020 and Biohaven's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 filed with the Securities and Exchange Commission on November 9, 2020. The forward-looking statements are made as of this date and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.