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
jennifer.porcelli@biohavenpharma.com
201-248-0741
Media Contact
Mike
Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502
REFERENCES FOR REVIEW:
- 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.
- 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.
- Sances G, Granella F, Nappi RE, et al. Course of
migraine during pregnancy and postpartum: A prospective
study. Cephalalgia 2003;23:197–205.
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.