SAN DIEGO, Sept. 11, 2020 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (Nasdaq: NBIX) today announced new data from
two post-hoc analyses of Phase III data, demonstrating that
once-daily ONGENTYS® (opicapone) capsules decreased
"off" time and increased "on" time without troublesome dyskinesia
as an add-on therapy to levodopa/carbidopa in patients with
Parkinson's disease who experience motor
fluctuations. Neurocrine Biosciences also presented real-world
data showing the increased burden motor fluctuations have over time
on Parkinson's disease patients and the healthcare system through
significantly more hospitalizations and emergency room visits.
These data are among several studies and analyses of ONGENTYS being
presented in collaboration with BIAL at the MDS Virtual Congress
2020 on September 12–16
(www.mdscongress.org/Congress/Registration.htm).
ONGENTYS, approved by the U.S. Food and Drug Administration in
April 2020, is the first and only
once-daily catechol-O-methyltransferase (COMT) inhibitor approved
as an add-on to levodopa/carbidopa in patients with Parkinson's
disease experiencing "off" episodes and will be available to
wholesalers in September.
"As Parkinson's disease progresses and treatment with
levodopa/carbidopa begins to wear off between treatment doses, many
patients begin to experience increased motor fluctuations,"
said Robert A. Hauser, M.D., Professor of Neurology and
Director, University of South Florida
Parkinson's Disease and Movement Disorders Center. "The Phase III
post-hoc data analyses demonstrated the benefit of adding
once-daily ONGENTYS to levodopa/carbidopa in patients with
Parkinson's disease who have motor fluctuations. Patients with
Parkinson's disease now have a new treatment option to help
provide more control of motor symptoms."
Data from a pooled post-hoc, sub-group analysis of Phase III
studies demonstrated that ONGENTYS 50 mg significantly reduced
"off" time by more than an hour compared to placebo when used as an
add-on treatment in patients with Parkinson's disease treated with
levodopa/carbidopa plus placebo at baseline (109.2 minutes for
ONGENTYS 50 mg [n=67] vs. 40.3 minutes for placebo [n=59];
p=0.0161).
In a separate post-hoc analysis, ONGENTYS significantly
increased absolute "on" time by approximately one additional hour
compared with entacapone (124 minutes [n=50] vs. 60 minutes [n=47];
p=0.0344) when used as the first COMT inhibitor add-on therapy to
levodopa/carbidopa in patients with Parkinson's disease recently
diagnosed with motor fluctuations.
"These data analyses demonstrated the benefit of adding
once-daily ONGENTYS to levodopa/carbidopa earlier in the treatment
regimen of patients with Parkinson's disease. In addition to
decreasing 'off' time the data also show that ONGENTYS
significantly increased 'on' time compared to an older COMT
inhibitor to help control motor fluctuations in patients with
Parkinson's disease," said Eiry W. Roberts, MD, Chief Medical
Officer, Neurocrine Biosciences. "We are looking forward to
bringing ONGENTYS to patients as a new add-on treatment option as
data from our real-world study show that the debilitating symptoms
of Parkinson's disease result in more hospitalizations and
emergency room visits, impacting the healthcare system in the
U.S."
Neurocrine Biosciences also presented real-world data from a
retrospective medical chart review of adult patients with
Parkinson's disease who began experiencing motor fluctuations while
taking levodopa. Of the 310 patients included in the review, 117
(38%) had a history of motor fluctuations of ≥ 2 years. Data show
that emergency department visits were significantly more frequent
in patients with Parkinson's disease with a longer history of motor
fluctuations (≥2 years) compared to patients with a shorter history
(13% [n=15] vs. 3% [n=5]; P<0.001). Similarly, hospitalizations
were significantly more frequent in patients with a longer history
of motor fluctuations (15% [n=18] vs 6% [n=12], P<0.01). Among
patients who were hospitalized, the mean length of stay was shorter
in patients with motor fluctuations ≥2 years versus patients with
motor fluctuations <2 years, but the difference was not
statistically significant (0.5 vs 1.1 days; P>0.05).
About the BIPARK-1 Study
BIPARK-1 was a Phase III,
randomized, double-blind placebo- and active-controlled study of
ONGENTYS as an adjunct to levodopa therapy in which approximately
600 patients with Parkinson's disease and motor fluctuations
received once-daily doses of opicapone (5 mg, 25 mg, or 50 mg),
placebo, or 200 mg doses of the COMT inhibitor entacapone for 14 to
15 weeks. The primary endpoint was the change from baseline in
absolute time in the "off" state, as assessed by patient diaries.
The initial study period was followed by a one-year open-label
phase during which all patients received treatment with
opicapone.
About the BIPARK-2 Study
BIPARK-2 was a Phase III,
randomized, double-blind placebo-controlled study of opicapone as
an adjunct to levodopa therapy in which approximately 400 patients
with Parkinson's disease and motor fluctuations received once-daily
doses of opicapone (25 mg or 50 mg) or placebo for 14 to 15 weeks.
The primary endpoint was the change from baseline in absolute time
in the "off" state, as assessed by patient diaries. The initial
study period was followed by a one-year open-label phase during
which all patients received treatment with opicapone.
BIPARK-1 and BIPARK-2 were conducted by BIAL – Portela
& CA, S.A. (BIAL). Neurocrine
Biosciences in-licensed opicapone from BIAL in 2017 and has
exclusive development and commercialization rights in the U.S.
and Canada. BIAL received approval from the European
Commission for ONGENTYS as an adjunct therapy to preparations of
levodopa/DOPA decarboxylase inhibitors in adult patients with
Parkinson's disease and end-of-dose motor fluctuations who cannot
be stabilized on those combinations. BIAL currently markets
ONGENTYS in Germany, United
Kingdom, Spain, Portugal and Italy.
About Parkinson's Disease
Parkinson's disease is a
chronic, progressive and debilitating neurodegenerative disorder
that affects approximately one million people in the United
States and six million people worldwide. Parkinson's disease
is associated with low dopamine levels produced in the brain.
Dopamine helps transmit signals between the areas of the brain that
control all purposeful movements, including talking, walking and
writing. As Parkinson's disease progresses, dopamine
production steadily decreases, resulting in increased problems with
motor symptoms including slowed movement (bradykinesia), tremor,
rigidity, impaired posture and balance, and difficulty with speech
and writing.
There is presently no cure for Parkinson's disease and
management of the disease consists of the use of treatments that
attempt to control motor symptoms primarily through dopaminergic
mechanisms. The current gold standard for treatment of motor
symptoms is levodopa/carbidopa. While levodopa/carbidopa improves
patients' motor symptoms, as the disease progresses, the beneficial
effects of levodopa begin to wear off more quickly. Patients then
experience motor fluctuations throughout the day between "on" time,
periods when the medication is working and Parkinson's disease
symptoms are controlled, and "off" time, when the medication is not
working, and motor symptoms return.
About ONGENTYS® (opicapone)
Capsules
ONGENTYS is a unique, once-daily, oral, peripheral, selective and
reversible catechol-O-methyltransferase (COMT) inhibitor approved
by the U.S. Food and Drug Administration (FDA) as an add-on
treatment to levodopa/carbidopa in patients with Parkinson's
disease experiencing "off" episodes. ONGENTYS inhibits the COMT
enzyme, which breaks down levodopa, making more levodopa available
to reach the brain.
Important Information
Approved Use
ONGENTYS® (opicapone) capsules is a
prescription medicine used with levodopa and carbidopa in people
with Parkinson's disease (PD) who are having "OFF" episodes.
It is not known if ONGENTYS is safe and effective in children.
Important Safety Information
Do not take ONGENTYS
if you:
- take a type of medicine called a non-selective
monoamine-oxidase (MAO) inhibitor.
- have a tumor that secretes hormones known as
catecholamines.
Before taking ONGENTYS, tell your healthcare provider about
all of your medical conditions, including if you:
- have daytime sleepiness from a sleep disorder, have unexpected
periods of sleep or sleepiness, or take a medicine to help you
sleep or that makes you feel sleepy.
- have had intense urges or unusual behaviors, including
gambling, increased sex drive, binge eating, or compulsive
shopping.
- have a history of uncontrolled sudden movements
(dyskinesia).
- have had hallucinations or psychosis.
- have liver or kidney problems.
- are pregnant or plan to become pregnant, or are breastfeeding
or plan to breastfeed.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements. Especially tell your
healthcare provider if you take nonselective MAO inhibitors (such
as phenelzine, tranylcypromine, and isocarboxazid) or catecholamine
medicines (such as isoproterenol, epinephrine, norepinephrine,
dopamine, and dobutamine), regardless of how you take the medicine
(by mouth, inhaled, or by injection).
ONGENTYS and other medicines may affect each other causing side
effects. ONGENTYS may affect the way other medicines work, and
other medicines may affect how ONGENTYS works.
What should I avoid while taking ONGENTYS?
- Do not drive, operate machinery, or do other dangerous
activities until you know how ONGENTYS affects you.
What are the possible side effects of
ONGENTYS?
ONGENTYS may cause serious side effects,
including:
- Falling asleep during normal activities such as driving
a car, talking or eating while taking ONGENTYS or other medicines
used to treat Parkinson's disease, without being drowsy or without
warning. This may result in having accidents. Your chances of
falling asleep while taking ONGENTYS are higher if you take other
medicines that cause drowsiness.
- Low blood pressure or dizziness, light headedness, or
fainting.
- Uncontrolled sudden movements (dyskinesia). ONGENTYS may
cause uncontrolled sudden movements or make such movements worse or
happen more often.
- Seeing, hearing, or feeling things that are not real
(hallucinations), believing things that are not real
(delusions), or aggressive behavior.
- Unusual urges (impulse control and compulsive disorders)
such as urges to gamble, increased sexual urges, strong urges to
spend money, binge eating, and the inability to control these
urges.
Tell your healthcare provider if you experience any of these
side effects or notice changes in your behavior.
The most common side effects of ONGENTYS
include uncontrolled sudden movements (dyskinesia),
constipation, increase in an enzyme called blood creatine kinase,
low blood pressure, and weight loss.
These are not all of the possible side effects of ONGENTYS. Call
your healthcare provider for medical advice about side effects. You
may report side effects to FDA at 1-800-FDA-1088.
Please see ONGENTYS full Product Information.
About Neurocrine Biosciences
Neurocrine
Biosciences is a neuroscience-focused, biopharmaceutical
company with 28 years of experience discovering and developing
life-changing treatments for people with serious, challenging and
under-addressed neurological, endocrine and psychiatric disorders.
The company's diverse portfolio includes FDA-approved treatments
for tardive dyskinesia, Parkinson's disease, endometriosis* and
uterine fibroids*, with three pivotal and five mid-stage clinical
programs in multiple therapeutic areas. Headquartered in San
Diego, Neurocrine Biosciences specializes in targeting
and interrupting disease-causing mechanisms involving the
interconnected pathways of the nervous and endocrine systems. For
more information, visit neurocrine.com, and follow the
company on LinkedIn. (*in collaboration with
AbbVie)
Forward Looking Statement
In addition to historical
facts, this press release contains forward-looking statements that
involve a number of risks and uncertainties. These statements
include, but are not limited to, statements related to the benefits
to be derived from ONGENTYS; the size of the potential market for
ONGENTYS; the value ONGENTYS brings to patients; the timing of
ONGENTYS's availability; the ability of Neurocrine Biosciences to
ensure patients have access to ONGENTYS; our expectations regarding
business and financial impacts of the COVID-19 pandemic, including
with respect to ONGENTYS availability and the ONGENTYS commercial
supply chain and other business operations; and whether results
from ONGENTYS's clinical trial results are indicative of real-world
results. Among the factors that could cause actual results to
differ materially from those indicated in the forward-looking
statements are: risks and uncertainties associated with the scale
and duration of the COVID-19 pandemic and resulting global,
national, and local economic and financial disruptions; risk and
uncertainties related to any COVID-19 quarantines, shelter-in-place
and similar government orders that are currently in place or that
may be put in place in the future, including the impact of such
orders on our business operations and the business operations of
the third parties on which we rely; risks and uncertainties
associated with Neurocrine Biosciences' business and finances in
general, as well as risks and uncertainties associated with the
commercialization of ONGENTYS; whether ONGENTYS receives adequate
reimbursement from third-party payors; the degree and pace of
market uptake of ONGENTYS; risks and uncertainties relating to
competitive products and technological changes that may limit
demand for ONGENTYS; risks that additional regulatory submissions,
for ONGENTYS or other product candidates, may not occur or be
submitted in a timely manner; risks that the FDA or other
regulatory authorities may make adverse decisions regarding
ONGENTYS; risks that post-approval ONGENTYS commitments or
requirements may be delayed; risks that ONGENTYS may be precluded
from commercialization by the proprietary rights of third parties,
or have unintended side effects, adverse reactions or incidents of
misuse; risks and uncertainties relating to competitive products
and technological changes that may limit demand for ONGENTYS; risks
associated with the Company's dependence on BIAL for the commercial
supply of, and manufacturing activities related to, ONGENTYS, and
the ability of the Company to manage BIAL; and other risks
described in the Company's periodic reports filed with the
Securities and Exchange Commission, including without limitation
the Company's quarterly report on Form 10-Q for the quarter ended
June 30, 2020. Neurocrine disclaims
any obligation to update the statements contained in this press
release after the date hereof.
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SOURCE Neurocrine Biosciences, Inc.