NEW HAVEN, Conn., March 12, 2020 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company (NYSE: BHVN) today 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 an 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.
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. For more
information about NURTEC ODT, visit www.nurtec.com.
About Migraine
Nearly 40 million people in the
U.S. suffer from migraine and the World Health Organization
classifies migraine as one of the 10 most disabling medical
illnesses. Migraine is characterized by debilitating attacks
lasting four to 72 hours with multiple symptoms, including
pulsating headaches of moderate to severe pain intensity that can
be associated with nausea or vomiting, and/or sensitivity to sound
(phonophobia) and sensitivity to light (photophobia). There is a
significant unmet need for new acute treatments as more than 90
percent of migraine sufferers are unable to work or function
normally during an attack.
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 (rimegepant) 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.
Please click here for full Prescribing
information.
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.
Please click here for full Prescribing information and Patient
Information.
About Biohaven
Biohaven is a biopharmaceutical
company focused on the development and commercialization of
innovative best-in-class therapies to improve the lives of patients
with debilitating neurological and neuropsychiatric diseases.
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: calcitonin gene-related peptide (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. For more information, visit
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", "on track", "expects" and
"will" 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 the
Company's management about NURTEC ODT as an acute treatment for
patients with migraine. Forward-looking statements include those
related to: the Company'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 the Company'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 the Company's product candidates, the potential for the
Company's product candidates to be first in class or best in class
therapies and the effectiveness and safety of the Company's product
candidates. 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 the
Company's Annual Report on Form 10-K filed with the Securities and
Exchange Commission on February 26,
2020. The forward-looking statements are made as of this
date and the Company 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.
Biohaven Contact
Dr. Vlad Coric
Chief Executive Officer
Vlad.Coric@biohavenpharma.com
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.