NEW HAVEN, Conn., Feb. 27, 2020 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced
that the U.S. Food and Drug Administration (FDA) has approved
NURTEC™ ODT (rimegepant) for the acute treatment of migraine in
adults. NURTEC ODT is the first FDA-approved product for Biohaven,
a company dedicated to advancing innovative therapies for
neurological diseases.
A single quick-dissolving tablet of NURTEC ODT can provide fast
pain relief and return patients to normal function within one hour,
and deliver sustained efficacy that lasts up to 48 hours for many
patients. NURTEC ODT disperses almost instantly in a person's mouth
without the need for water, offering people with migraine a
convenient, discreet way to take their medication anytime and
anywhere they need it. NURTEC ODT is not indicated for the
preventive treatment of migraine. Biohaven expects topline results
from its prevention of migraine trial later this quarter.
Vlad Coric, M.D., CEO of
Biohaven commented, "The FDA approval of NURTEC ODT marks an
important milestone for the migraine community and a transformative
event for Biohaven. Millions of people suffering from migraine are
often not satisfied with their current acute treatment, at times
having to make significant tradeoffs because of troublesome side
effects and reduced ability to function. NURTEC ODT is an important
new oral acute treatment for migraine that offers patients the
potential to quickly reduce and eliminate pain and get back to
their lives." Dr. Coric added, "We believe NURTEC ODT will be
the first of many innovative Biohaven medicines to become available
to treat devastating neurological diseases, a therapeutic category
many other companies have abandoned. We are dedicated to helping
patients with these conditions, who often have limited or no
treatment options, live better, more productive lives."
NURTEC ODT, with its novel quick-dissolve oral tablet
formulation, works by blocking CGRP receptors, treating a root
cause of migraine. 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 Enforcement
Administration.
NURTEC ODT may offer an alternative treatment option,
particularly for patients who experience inadequate efficacy, poor
tolerability, or have a contraindication to currently available
therapies. More than 3,100 patients have been treated with
rimegepant with more than 113,000 doses administered in clinical
trials, including a one-year long-term safety study. 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.
Mary Franklin, Executive Director
of the National Headache Foundation commented, "Everyone knows
someone living with migraine, yet it remains an invisible disease
that is often overlooked and misunderstood. Almost all people with
migraine need an acute treatment to stop a migraine attack as it
occurs, which can happen without warning. The approval of NURTEC
ODT is exciting for people with migraine as it provides a new
treatment option to help people regain control of their attacks and
their lives."
Peter Goadsby, M.D.,
Ph.D., Professor of Neurology and Director of the King's
Clinical Research Facility, King's College Hospital
commented, "I see many patients in my practice whose lives are
disrupted by migraine, afraid to go about everyday life in case of
a migraine attack. Many feel unsure if their acute treatment will
work and if they can manage the side effects. With the FDA approval
of NURTEC ODT, there is renewed hope for people living with
migraine that they can get back to living their lives without fear
of the next attack."
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 Phase 3 trial, NURTEC
ODT achieved statistical significance on the regulatory co-primary
endpoints of pain freedom and freedom from most bothersome symptom
(MBS) at two hours post dose compared to placebo. NURTEC ODT also
demonstrated statistical superiority at one hour for pain relief
(reduction of moderate or severe pain to no pain or mild pain) and
return to normal function. The benefits of pain freedom, pain
relief, return to normal function and freedom from MBS were
sustained up to 48 hours for many patients. Importantly, these
benefits were seen with only a single dose of NURTEC ODT.
Eighty-six percent of patients treated with NURTEC ODT did not
require rescue medication (e.g. NSAIDS, acetaminophen) within 24
hours post dose. The long-term safety study assessed the safety and
tolerability of rimegepant with multiple doses used over up to one
year. The study evaluated 1,798 patients, who used rimegepant 75 mg
as needed to treat migraine attacks, up to one dose per day. The
study included 1,131 patients who were exposed to rimegepant for at
least six months, and 863 who were exposed for at least one year,
all of whom treated an average of at least two migraine attacks per
month. The safety of treating more than 15 migraines in a 30-day
period has not been established.
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.
Biohaven Conference Call Information
Biohaven is
hosting a conference call and webcast on Friday, February 28, 2020, at 8:00 a.m. ET. Participants are invited to
join the conference by dialing 877-407-9120 (toll-free)
or 412-902-1009 (international). To access the audio webcast with
slides, please visit the "Events & Presentations" page in the
Investors section of the Company's website.
Biohaven's Commitment to Patient
Access
Biohaven is committed to
supporting the migraine community by eliminating barriers to
medication access. The company has launched a patient support
program. For more information and to enroll, please call
1-833-4-NURTEC or visit www.nurtec.com.
NURTEC ODT will be available in pharmacies in early March 2020 in packs of eight tablets. Each eight
tablet pack 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.
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.
What is NURTEC ODT?
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
Media Contact
Mike Beyer, Sam Brown Inc.
(312) 961-2502
mikebeyer@sambrown.com
NURTEC is a trademark of Biohaven Pharmaceutical Holding Company
Ltd.
Copyright © 2020 Biohaven. All rights reserved.
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.