NEW HAVEN, Conn., April 1, 2022 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), today announced that data from an open-label, single-center, phase 1 study evaluating the excretion of a single dose of rimegepant 75 mg in the breast milk of healthy lactating women has been published in the peer-reviewed journal, Breastfeeding medicinethe official journal of the Academy of Breastfeeding Medicine.
This study is particularly important because migraine affects more than 30 million women in America and is the most common cause of disability in women of childbearing age (15 to 49 years old).1.2 Often, in women with migraine, attacks may subside during pregnancy but resume within 4 weeks of delivery.3 Given the lack of scientific information on migraine medications for breastfeeding mothers, women are often apprehensive about taking their migraine medications while breastfeeding.
The results of the study showed that the excretion of rimegepant in breast milk is very low and that rimegepant was safe and well tolerated by lactating women. It was estimated that on a weight-adjusted basis, a breastfed infant would receive
Robert CroupMD, Development Manager – Neurology at Biohaven, said: “This is important data for women of childbearing age with migraine, as it provides useful new information for those who breastfeed and wish to breastfeed their babies. Grateful the lack of data available on migraine medication for breastfeeding women, Biohaven is proud to take a science-based approach by conducting a clinical study in this population.”
The study evaluated 12 healthy breastfeeding women who received a single dose of rimegepant 75 mg with a 36-hour follow-up. The primary objective of this study was to determine whether rimegepant is excreted in breast milk after a single 75 mg dose and to determine the concentration-time profiles of rimegepant in breast milk and plasma of healthy lactating women.
Thomas W. HalePh.D., Professor of Pediatrics and Associate Dean of Research at Texas Tech University Health Sciences Center School of Medicine, said, “I am very pleased with the results of this clinical trial. Nursing mothers often end up having to choose between taking migraine medication or breastfeeding their babies. Most of the questions we receive at the InfantRisk Center relate to using migraine medication while breastfeeding. Now, thanks to this research, we can share with breastfeeding mothers that there is clinical data supporting a treatment option while breastfeeding.
Dr. Hale and Therese BakerMD, Associate Professor and Chair of the Department of Obstetrics and Gynecology at Texas Tech University Health Sciences Center School of Medicine, are co-authors of the publication.
About NURTEC ODT
NURTEC® ODT (rimegepant) is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-dissolving ODT formulation approved by the United States Food and Drug Administration (FDA) for acute treatment migraine with or without aura and preventive treatment of episodic migraine in adults. CGRP neuropeptide activity is thought to play a causal role in the pathophysiology of migraine. NURTEC ODT is a CGRP receptor antagonist that works by reversibly blocking CGRP receptors, thereby inhibiting the biological activity of the CGRP neuropeptide. For more information about NURTEC ODT, visit www.nurtec.com.
Rimegepant is available as Nurtec® ODT in United States for the acute and preventive treatment of migraine in adults. Biohaven and Pfizer Inc. recently announced a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency recommending the marketing authorization of rimegepant 75 mg for the acute and preventive treatment of migraine. If approved, the trade name will be Vydura™ in the European Union.
Indication
NURTEC ODT orally disintegrating tablets are a prescription medication used to treat migraine in adults. It is intended for the acute treatment of migraine attacks with or without aura and for the preventive treatment of episodic migraine. It is not known if NURTEC ODT is safe and effective in children.
Important Safety Information
Do not take NURTEC ODT if you are allergic to NURTEC ODT (rimegepant) or any of its ingredients. Before taking NURTEC ODT, tell your healthcare provider (HCP) about all your medical conditions, including if you:
- have liver problems,
- have kidney problems,
- are pregnant or plan to become pregnant,
- are breastfeeding or planning to breastfeed.
Tell your healthcare professional about all medications you take, including prescription and over-the-counter medications, vitamins, and herbal supplements.
NURTEC ODT can cause serious side effects, including allergic reactions, difficulty breathing, and skin rashes. This may occur several days after taking NURTEC ODT. Call your healthcare professional or get emergency help right away if you have swelling of your face, mouth, tongue, or throat or have difficulty breathing. This occurred in less than 1% of patients treated with NURTEC ODT.
The most common side effects of NURTEC ODT were nausea (2.7%) and stomach pain/indigestion (2.4%). These are not the only possible side effects of NURTEC ODT. Tell your HCP if you have any side effects.
We encourage you to report side effects of prescription drugs to the FDA.
To visit www.fda.gov/medwatch or call 1-800-FDA-1088 or report side effects to Biohaven at 1-833-4NURTEC.
See complete Prescribing Information and Patient Information.
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-cleared NURTEC ODT (rimegepant) for the acute and preventative treatment of migraine and a broad portfolio of late-stage product candidates on three distinct mechanistic platforms: CGRP receptor antagonism for acute treatment and preventive of migraine; glutamate modulation for obsessive-compulsive disorder and spinocerebellar ataxia; and MPO inhibition for amyotrophic lateral sclerosis; Ion channel activators Kv7 (Kv7) and myostatin. More information about Biohaven is available at www.biohavenpharma.com.
Forward-looking statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including “believe”, “continue”, “may”, “will”, “anticipate”, “expect” and similar expressions, are intended to identify forward-looking statements. Such forward-looking statements involve substantial risks and uncertainties, including statements based on Biohaven management’s current expectations and assumptions regarding NURTEC ODT as a as acute treatment for patients with migraine and preventative treatment of migraine. Factors that could affect these forward-looking statements include those related to: Biohaven’s ability to effectively market NURTEC ODT, delays or problems in supply or manufacturing of NURTEC ODT, compliance with applicable U.S. regulatory requirements, timing, commencement and expected results of Biohaven planned and ongoing clinical trials timing of anticipated interactions and FDA filings timing and results of expected regulatory filings potential commercialization of Biohaven’s product candidates potential for Biohaven’s product candidates to be first-in-class or best-in-class treatments and the efficacy and safety of Biohaven’s product candidates. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by the forward-looking statements. Other important factors to consider in making forward-looking statements are described in the “Risk Factors” section of the company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 25, 2022, and in Biohaven’s subsequent filings with the Securities and Exchange Commission. Forward-looking statements are made as of the date of this new release, and Biohaven undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. ‘required.
NURTEC and NURTEC ODT are registered trademarks of Biohaven Pharmaceutical Ireland DAC. Neuroinnovation is a registered trademark of Biohaven Pharmaceutical Holding Company Ltd.
Contact
Jennifer Porcelli
Vice President, Investor Relations
[email protected]
201-248-0741
Media Contact
Mike Beyer
Sam Brown Inc.
[email protected]
312-961-2502
REFERENCES TO REVIEW:
- GBD 2019 Illness and Injury Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the 2019 Global Burden of Disease Study. Lancet 2020;396:1204–1222.
- GBD 2016 Headache Collaborators. Global, regional and national burden of migraine and tension-type headaches, 1990-2016: A systematic analysis for the Global Burden of Disease Study 2016. Neurol Lancet 2018;17:954–976.
- Sances G, Granella F, Nappi RE, et al. Evolution of migraine during pregnancy and postpartum: A prospective study. Headache 2003;23:197–205.
SOURCE Biohaven Pharmaceutical Holding Company Ltd.
