SAN DIEGO, Sept. 14, 2020 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (Nasdaq: NBIX) today announced that 50 mg
capsules of ONGENTYS® (opicapone), the first and only
FDA-approved once-daily catechol-O-methyltransferase (COMT)
inhibitor, are now available by prescription in the United States. ONGENTYS was approved by
the U.S. Food and Drug Administration (FDA) on April 24, 2020, as an add-on treatment to
levodopa/carbidopa in patients with Parkinson's disease
experiencing "off" episodes.
Experience the interactive Multichannel News Release here:
https://www.multivu.com/players/English/8773451-neurocrine-biosciences-ongentys-now-available/
Parkinson's disease is the second most common neurodegenerative
disorder in the United States
after Alzheimer's disease. About one million Americans have
Parkinson's disease and each year, an estimated 50,000 people in
the United States are newly
diagnosed with this chronic, progressive and debilitating
neurodegenerative disorder.
"ONGENTYS is a new treatment option that decreases 'off' time,
the period of time during the day when Parkinson's disease symptoms
are bothersome, and increases 'on' time without troublesome
dyskinesia, the period of time during the day when Parkinson's
disease symptoms are better controlled," said Rebecca Gilbert, M.D., Ph.D., Vice President and
Chief Scientific Officer of the American Parkinson Disease
Association. "The approval of ONGENTYS is welcome news to people
with Parkinson's disease who are looking for additional medication
possibilities to help control the often difficult symptoms of the
disease that negatively impact their lives."
ONGENTYS is an oral, selective COMT inhibitor that helps block
the COMT enzyme that breaks down levodopa, the gold standard
therapy for controlling motor symptoms in patients with Parkinson's
disease. ONGENTYS helps protect levodopa by reducing its breakdown
in the bloodstream, making more levodopa available to reach the
brain.
"Parkinson's disease is a progressive, debilitating condition
where people often struggle to control motor fluctuations,
impacting many aspects of their daily life," said Eiry W. Roberts,
M.D., Chief Medical Officer at Neurocrine Biosciences. "The
availability of ONGENTYS offers hope to patients by significantly
reducing daily 'off' time, when symptoms return between regular
doses of levodopa/carbidopa. The availability of ONGENTYS
underscores our commitment to delivering innovative therapies that
address unmet medical needs in patients living with movement
disorders."
Neurocrine Biosciences INBRACE® Support Program
supports patients who are prescribed ONGENTYS along their treatment
journey including information on prescription fulfillment,
navigating health insurance coverage requirements and financial
assistance. For more information, patients may visit
www.INBRACEsupportprogram.com.
The FDA approval of ONGENTYS is supported by data from 38
clinical studies, including two multinational Phase III clinical
studies (BIPARK-1 and BIPARK-2), with more than 1,000 Parkinson's
disease patients treated with ONGENTYS. In the BIPARK-1 trial,
approximately 600 patients with Parkinson's disease and motor
fluctuations received one of three doses of ONGENTYS (5 mg, 25 mg
or 50 mg), placebo, or 200 mg doses of the COMT inhibitor
entacapone for 14 or 15 weeks. In the BIPARK-2 trial, approximately
400 patients received one of two doses of ONGENTYS (25 mg or 50 mg)
or placebo for 14 or 15 weeks. Both studies included a one-year
open-label extension. Data from both trials showed that ONGENTYS 50
mg significantly reduced "off" time from baseline to week 14 or 15
compared to placebo. "On" time without troublesome dyskinesia also
increased from baseline to week 14 or 15 compared to placebo.
Pooled safety data from the BIPARK-1 and BIPARK-2 studies
indicated that the most common adverse reactions across all
patients treated with ONGENTYS (incidence at least 4% and greater
than placebo) were dyskinesia, constipation, blood creatine kinase
increase, hypotension/syncope, and weight decrease.
In June 2016, BIAL – Portela & CA,
S.A. (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. Neurocrine
Biosciences in-licensed opicapone from BIAL in 2017 and has
exclusive development and commercialization rights in the United States and Canada.
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 caused by 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 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 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 Statements
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.