Nurtec (rimegepant) Lactation Clinical Study Published in Breastfeeding Medicine Journal

NEW HAVEN, Conn., April 1, 2022 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), today announced that data from a Phase 1, single-center, open-label study evaluating the excretion of a single dose of rimegepant 75 mg in the human milk of healthy lactating women was published in the peer-reviewed journal, Breastfeeding Medicine, the official journal of the Academy of Breastfeeding Medicine.

This study is particularly important as migraine affects more than 30 million women in America and is the most common cause of disability among women of reproductive age (15 – 49 years).^1,2 Often for women with migraine, attacks may subside during pregnancy but resume within 4 weeks of childbirth.³ Given a lack of science-based information about migraine medication for nursing mothers, women are often apprehensive about taking their migraine medications while breastfeeding.

The results of the study showed that excretion of rimegepant into human milk is very low and rimegepant was safe and well tolerated by lactating women. It was estimated that on a weight-adjusted basis, a nursing infant would receive <1% of the maternal dose of rimegepant which is much below the commonly cited safety threshold of <10% of the maternal dose. Further, there were no serious adverse events and no participants discontinued the study due to treatment related adverse events.

Robert Croop, M.D., Chief Development Officer - Neurology at Biohaven commented, "This is important data for women of reproductive age with migraine as it provides helpful new information for those who are lactating and wish to breastfeed their infants. Recognizing the lack of available data on migraine medications 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 lactating women who were administered a single-dose of rimegepant 75 mg with a 36-hour follow-up. The primary objective of this study was to investigate whether rimegepant is excreted in human milk after a single 75 mg dose and to determine the concentration–time profiles of rimegepant in the human milk and plasma of healthy lactating women.

Thomas W. Hale, Ph.D., Professor of Pediatrics and Associate Dean for Research at Texas Tech University Health Sciences Center School of Medicine, noted, "I'm very pleased with the results of this clinical trial. Lactating mothers often end up having to choose between taking a migraine medication or breastfeeding their infant. Many of the questions we receive at the InfantRisk Center are about using migraine medications when breastfeeding. Now, with this research, we can share with lactating mothers that there is clinical data supporting a treatment option during breastfeeding."

Dr. Hale and Teresa Baker, M.D., Associate Professor and Chair of the Department of Obstetrics and Gynecology at Texas Tech University Health Sciences Center School of Medicine, are coauthors of the 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 with or without aura and the preventive treatment of episodic 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. For more information about NURTEC ODT, visit www.nurtec.com.

Rimegepant is available as Nurtec® ODT in the United States for the acute and preventive treatment of migraine in adults. Biohaven and Pfizer Inc. recently announced a positive opinion by the Committee for Medicinal Products for Human Use of the European Medicines Agency recommending the marketing authorization for 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 is a prescription medicine that is used to treat migraine in adults. It is for the acute treatment of migraine attacks with or without aura and 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 you take 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,
• breastfeeding or plan to breastfeed.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

NURTEC ODT may cause serious side effects including allergic reactions, trouble breathing and rash. This can happen days after you take NURTEC ODT. Call your HCP or get emergency help right away if you have swelling of the face, mouth, tongue, or throat or trouble 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.

You are encouraged to report side effects of prescription drugs to the FDA. 

Visit www.fda.gov/medwatch or call 1–800–FDA–1088 or report side effects to Biohaven at 1–833–4NURTEC.

See full 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-approved NURTEC ODT (rimegepant) for the acute and preventive 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, and spinocerebellar ataxia; and MPO inhibition for amyotrophic lateral sclerosis; Kv7 Ion Channel Activators (Kv7), and Myostatin. More information about Biohaven is available at www.biohavenpharma.com.

Forward-looking Statement
This news release includes 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. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Biohaven's management about NURTEC ODT as an acute treatment for patients with migraine and preventive treatment for migraine. Factors that could affect these forward-looking statements include those related to: Biohaven's ability to effectively commercialize NURTEC ODT, delays or problems in the supply or manufacture of NURTEC ODT, complying with applicable U.S. regulatory requirements, 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, the potential commercialization of Biohaven's product candidates, 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. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by forward-looking statements. Additional important factors to be considered in connection with 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. The forward-looking statements are made as of the date of this new release, 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.

NURTEC and NURTEC ODT are registered trademarks of Biohaven Pharmaceutical Ireland DAC. Neuroinnovation is a trademark of Biohaven Pharmaceutical Holding Company Ltd.

Biohaven 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 FOR REVIEW:

1. GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: A systematic analysis for the Global Burden of Disease Study 2019. Lancet 2020;396:1204–1222. 
2. GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990–2016: A systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 2018;17:954–976.
3. Sances G, Granella F, Nappi RE, et al. Course of migraine during pregnancy and postpartum: A prospective study. Cephalalgia 2003;23:197–205.

SOURCE Biohaven Pharmaceutical Holding Company Ltd.