NEW HAVEN, Conn., July 15, 2020 /PRNewswire/ -- Khloé
Kardashian joins efforts with Biohaven Pharmaceuticals to
launch the Take Back Today campaign to empower people
with migraine to share their stories in an online community, learn
about new ways to manage their disease and get back to what matters
most – whether that is spending more time with family, friends, a
favorite hobby or work. For more than 20 years, Khloé has
experienced first-hand the debilitating impact of migraine, an
often-misunderstood disease, which inspired her to join this
campaign to help other people with migraine.
"Like others, my migraine blindsides me when it strikes and
takes away whatever I had planned for my day. When a migraine hits,
all I want to do is lie down in a quiet, dark room, and it leaves
me feeling isolated and helpless. I dread those migraine days and
fear that the migraine pain is going to be bad enough to keep me
from being there for my family, friends, work and most importantly,
my daughter," said entrepreneur, TV personality, executive producer
and mom, Khloé Kardashian. Khloé often faces migraine symptoms
such as intense pain, nausea, temporary impaired vision and
dizziness. She continued, "For too long, I have also had to deal
with the stigma that migraine is just another headache and that I
should just 'get it over it.' People don't understand how disabling
migraine can be, especially when I have to cancel plans at the last
minute."
Khloé has been working with her doctor to better manage her
migraine and she recently started using NURTEC™ ODT (rimegepant),
an orally dissolving tablet that is an acute treatment. Khloé
stated, "For me, NURTEC ODT was different than other treatments I
tried. NURTEC ODT worked fast and allowed me to get back to normal
so that I could take back my day. I'm sharing my story so
others with migraine do not feel alone and can be empowered to Take
Back Today from migraine."
In clinical trials, 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.
Khloé Kardashian adds, "I want to encourage people with
migraine not to give up hope and to continue to work with their
doctor to find something that works for them. Together, we can
build a strong community for people with migraine to express
themselves without judgement and learn from others how to get back
to what they love."
Nearly 40 million people have migraine, most of whom are women.
A recent survey, Perspectives of People with Migraine by the
National Headache Foundation and Biohaven, confirms that 93 percent
of people who don't suffer from migraine fail to understand the
severity of the disease. With Take Back Today,
Khloé hopes that other people living with this debilitating
disease join her on TakeBackToday.com or share their story using
#TakeBackToday.
Vlad Coric, M.D., CEO of Biohaven
commented, "It's impressive how much Khloé Kardashian has
accomplished in her career and for her family despite her
longstanding struggle with migraine since childhood.
Khloé's story resonates deeply with so many other people with
migraine and adds to what we have heard from them about the
disruptions they experience in their daily lives and how NURTEC ODT
has made a difference. I was particularly moved by Khloé's stories
about how migraines have impacted her life since sixth grade and
how well she has responded to NURTEC ODT. The Take Back
Today campaign speaks to Biohaven's commitment to patients and
communicates the importance of NURTEC ODT as a new acute treatment
of migraine for the millions of people suffering from the disease
that are not satisfied with their current therapy. We are grateful
to Khloé for her advocacy and passion to help others by
sharing her own experience with migraine and her treatment response
to NURTEC ODT."
NURTEC ODT is the first and only calcitonin gene-related
peptide (CGRP) receptor antagonist in an orally disintegrating
tablet (ODT) approved by the U.S. Food and Drug Administration
(FDA) for the acute treatment of migraine in adults. NURTEC ODT is
not indicated for the preventive treatment of migraine. A single
dose 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. The fast-dissolve
tablet 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 when and where they need
it.
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.
Learn more about Khloé Kardashian's story and from others
who are living with migraine at www.TakeBackToday.com or
follow them on Instagram, Facebook and Twitter using
@TakeBackToday.
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.
The most common adverse reaction was nausea (2% in patients who
received NURTEC ODT compared to 0.4% in patients who received
placebo). 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.
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.
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 Consumer Important Safety Information,
full Prescribing Information and Patient Information.
About Biohaven
Biohaven Pharmaceuticals is a
wholly owned subsidiary of Biohaven Pharmaceutical Holding Company
Ltd. (NYSE: BHVN) and 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: 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 Statements
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" 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 potential
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 our forward-looking
statements. Additional important factors to be considered in
connection with forward-looking statements are described in the
"Risk Factors" section of Biohaven's Annual Report on Form 10-K for
the year ended December 31, 2019,
filed with the Securities and Exchange Commission on February 26, 2020 and Biohaven's Quarterly Report
on Form 10-Q for the quarter ended March 31,
2020, filed with the Securities and Exchange Commission on
May 7, 2020. The forward-looking
statements are made as of this date 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.
Biohaven Contact:
Vlad
Coric, M.D.
Chief Executive Officer
Vlad.Coric@biohavenpharma.com
Media Contact:
Christy
Curran
Sam Brown Inc.
christycurran@sambrown.com
615-414-8668
NURTEC is a trademark of Biohaven Pharmaceutical Holding Company
Ltd.
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.