SAN
DIEGO, Aug. 29, 2023 /PRNewswire/
-- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today
presented findings from a data analysis of KINECT®-4
demonstrating a comparable pattern of improvement over time of
clinician-rated tardive dyskinesia (TD) severity and
awareness/distress as measured by the Abnormal Involuntary Movement
Scale (AIMS) and patient-reported TD impact as measured by the
Trajectories of Tardive Dyskinesia Impact Scale (TDIS). The data
(Poster #657) was presented at the MDS International Congress of
Parkinson's Disease and Movement Disorders® in
Copenhagen, Denmark.
The data analysis evaluated the use of INGREZZA for the
treatment of TD among all 167 patients with either schizophrenia or
mood disorders enrolled over the course of the Phase 3, open-label,
long-term study. On average, the analysis suggested that
clinician-rated TD severity as measured by AIMS and
patient-reported assessment of the physical, social and emotional
impact of TD as measured by TDIS decreased with one-capsule,
once-daily INGREZZA treatment over the course of the 48-week study.
Researchers concluded that the use of AIMS and TDIS in evaluating
symptom improvement during treatment may give a more complementary
understanding regarding the patient's TD experience.
"The use of AIMS and TDIS provides a more complete perspective
on the patient's TD experience," said Eiry W. Roberts, M.D., Chief
Medical Officer at Neurocrine Biosciences. "While AIMS is helpful
to assess TD severity as perceived by the healthcare provider and
to follow the severity of TD over time, TDIS enables us to assess
the physical, social and emotional impact of these involuntary
movements from the patient perspective. The insight gained from
these data also supports the efficacy of treatment with INGREZZA in
reducing both HCP-perceived severity and patient-reported impact of
TD."
The study showed that though AIMS and TDIS measure unique
aspects of TD, TDIS demonstrated a comparable pattern of
improvement to the AIMS total score, TD severity as measured by
AIMS item 8 (AIMS8), incapacitation as measured by AIMS item 9
(AIMS9) and awareness/distress as measured by AIMS item 10 (AIMS10)
over the 48-week treatment period.
Key results from the analysis demonstrated the following:
- Mean AIMS total score at baseline was 14.6 and decreased over
48 weeks, with a mean change from baseline of -10.2 (standard
deviation [SD]=1.2) for the 40 mg cohort and -11.0 (SD=0.5) for the
80 mg cohort, as assessed by site raters. (n=163)
- At baseline, TD severity was moderate (AIMS8 mean=3.2) and most
patients were aware of TD with moderate distress (AIMS10 mean=2.7).
TD severity and distress decreased, with most patients scored with
minimal severity (AIMS8=1) and as aware/no distress at 48 weeks
(AIMS10=1). (n=167)
- Mean TDIS scores decreased from 16.5 at baseline to 6.0 at
Week 48, indicating TD had a moderate impact on activity by the end
of the INGREZZA treatment period. (n=167)
Additional presentation at the MDS International Congress
of Parkinson's Disease and Movement Disorders®
includes:
- Crushing Valbenazine Capsule Contents for Potential
Addition to Soft Foods or Administration via G Tube (poster
#9)
About the KINECT-4 Phase 3 Study
KINECT®-4 is a Phase 3, open-label study, in
which 163 participants with moderate to severe TD and underlying
schizophrenia, schizoaffective disorder or mood disorder (including
bipolar disorder or major depressive disorder) received 48 weeks of
open-label treatment with once-daily INGREZZA (40 mg or 80 mg
capsules) followed by a four-week washout. Dosing was initiated at
40 mg/day in all participants, with escalation to 80 mg/day at Week
4 based on effectiveness and tolerability. Dose reduction to 40 mg
was allowed in participants who could not tolerate the 80 mg dose.
Patients were discontinued if the new dose was not tolerated.
Participants experienced TD improvements during long-term
treatment as demonstrated by mean change from baseline to Week 48
in AIMS total score (sum of items 1-7, evaluated by site raters)
with INGREZZA 40 mg/day (-10.2) or 80 mg/day (-11.0). Consistent
with previous studies, INGREZZA was generally well tolerated. After
Week 4, treatment emergent adverse events (TEAEs) that occurred in
≥ 5 percent of all participants (combined dose groups) were urinary
tract infection (8.5 percent) and headache (5.2 percent). Changes
from baseline in psychiatric stability, vital signs,
electrocardiogram parameters and laboratory test values were
generally small and not clinically significant.
About Tardive Dyskinesia (TD)
Tardive dyskinesia (TD)
is a movement disorder that is characterized by uncontrollable,
abnormal and repetitive movements of the face, torso and/or other
body parts, which may be disruptive and negatively impact patients.
The condition is associated with taking certain kinds of mental
health medicines (like antipsychotics) that help control dopamine
receptors in the brain. Taking antipsychotics commonly prescribed
to treat mental illnesses such as major depressive disorder,
bipolar disorder, schizophrenia and schizoaffective disorder, and
other prescription medicines (metoclopramide and prochlorperazine)
used to treat gastrointestinal disorders are associated with TD. In
patients with TD, these treatments are thought to result in
irregular dopamine signaling in a region of the brain that controls
movement. The symptoms of TD can be severe and are often persistent
and irreversible. TD is estimated to affect approximately 600,000
people in the United States.
About INGREZZA® (valbenazine)
Capsules
INGREZZA is the only one-capsule, once-daily
selective vesicular monoamine transporter 2 (VMAT2) inhibitor
approved by the U.S. Food and Drug Administration for the treatment
of adults with tardive dyskinesia and the treatment of chorea
associated with Huntington's disease (HD).
INGREZZA, developed by Neurocrine Biosciences, selectively
inhibits VMAT2 with no appreciable binding affinity for VMAT1,
dopaminergic (including D2), serotonergic, adrenergic,
histaminergic or muscarinic receptors. While the specific way
INGREZZA works to treat HD chorea is not fully understood, INGREZZA
selectively targets VMAT2 to inhibit the release of dopamine, a
chemical in the brain that helps control movement. INGREZZA is
believed to reduce extra dopamine signaling, which may lead to
fewer uncontrollable movements. Additionally, INGREZZA can be taken
for the treatment of tardive dyskinesia as one-capsule once-daily,
together with most psychiatric medications such as antipsychotics
or antidepressants. INGREZZA dosages approved for use are 40 mg, 60
mg and 80 mg capsules. INGREZZA is not approved in any other dosage
form.
Important Information
Approved Uses
INGREZZA® (valbenazine) capsules is a prescription
medicine used to treat adults with:
- movements in the face, tongue, or other body parts that cannot
be controlled (tardive dyskinesia).
- involuntary movements (chorea) of Huntington's
disease. INGREZZA does not cure the cause of involuntary
movements, and it does not treat other symptoms of Huntington's
disease, such as problems with thinking or emotions.
It is not known if INGREZZA is safe and effective in
children.
IMPORTANT SAFETY INFORMATION
VMAT2 inhibitors, including INGREZZA, can cause serious side
effects in people with Huntington's disease, including: depression,
suicidal thoughts, or suicidal actions. Tell your healthcare
provider before you start taking INGREZZA if you have Huntington's
disease and are depressed (have untreated depression or depression
that is not well controlled by medicine) or have suicidal thoughts.
Pay close attention to any changes, especially sudden changes, in
mood, behaviors, thoughts, or feelings. This is especially
important when INGREZZA is started and when the dose is changed.
Call your healthcare provider right away if you become depressed,
have unusual changes in mood or behavior, or have thoughts of
hurting yourself.
Do not take INGREZZA if you:
- are allergic to valbenazine, or any of the ingredients in
INGREZZA.
INGREZZA may cause serious side effects, including:
- Sudden swelling from an allergic reaction (angioedema).
Sudden swelling has happened after the first dose or after many
doses of INGREZZA. Signs and symptoms of angioedema
include: swelling of your face, lips, throat, and other areas
of your skin, difficulty swallowing or breathing, and raised, red
areas on your skin (hives). Swelling in the throat can be
life-threatening and can lead to death. Go to the nearest emergency
room right away if you develop these signs and symptoms. Your
healthcare provider should stop your treatment with INGREZZA.
- Heart rhythm problems (QT prolongation). INGREZZA
may cause a heart problem known as QT prolongation. Symptoms of
QT prolongation may include: fast, slow, or irregular
heartbeat, dizziness or fainting, or shortness of breath.
Tell your healthcare provider right away if you have a change in
your heartbeat (a fast or irregular heartbeat), or if you
faint.
- Neuroleptic Malignant Syndrome (NMS): NMS is a
serious condition that can lead to death. Call a healthcare
provider right away or go to the nearest emergency room if you
develop these symptoms and they do not have another obvious cause:
high fever, stiff muscles, problems thinking, very fast or uneven
heartbeat, or increased sweating.
- Abnormal movements (Parkinson-like). Symptoms
include: shaking, body stiffness, trouble moving or walking, or
keeping your balance.
Before taking INGREZZA, tell your healthcare provider about
all of your medical conditions including if you: have liver or
heart 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.
Sleepiness (sedation) is a common side effect with
INGREZZA. While taking INGREZZA, do not drive a car or operate
dangerous machinery until you know how INGREZZA affects you.
Drinking alcohol and taking other drugs that may also cause
sleepiness while you are taking INGREZZA may increase any
sleepiness caused by INGREZZA.
The most common side effect of INGREZZA in people with
tardive dyskinesia is sleepiness (somnolence).
The most common side effects of INGREZZA in people with
Huntington's disease are sleepiness (somnolence), allergic
itching, rash, and trouble getting to sleep or staying asleep.
These are not all of the possible side effects of INGREZZA. Call
your doctor for medical advice about side effects. You are
encouraged to report negative side effects of prescription drugs to
the FDA. Visit MedWatch at www.fda.gov/medwatch or
call 1-800-FDA-1088.
Please see INGREZZA full Prescribing
Information, including Boxed Warning.
About Neurocrine Biosciences, Inc.
Neurocrine
Biosciences is a leading neuroscience-focused, biopharmaceutical
company with a simple purpose: to relieve suffering for people with
great needs, but few options. We are dedicated to discovering and
developing life-changing treatments for patients with
under-addressed neurological, neuroendocrine, and neuropsychiatric
disorders. The company's diverse portfolio includes FDA-approved
treatments for tardive dyskinesia, chorea associated with
Huntington's disease, Parkinson's disease, endometriosis* and
uterine fibroids*, as well as a robust pipeline including multiple
compounds in mid- to late-phase clinical development across our
core therapeutic areas. For three decades, we have applied our
unique insight into neuroscience and the interconnections between
brain and body systems to treat complex conditions. We relentlessly
pursue medicines to ease the burden of debilitating diseases and
disorders, because you deserve brave science. For more information,
visit neurocrine.com, and follow the company on LinkedIn, Twitter
and Facebook. (*in collaboration with AbbVie)
NEUROCRINE, the Neurocrine logos, KINECT and INGREZZA are
registered trademarks of Neurocrine Biosciences, Inc.
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 regarding the potential
benefits to be derived from INGREZZA and the value INGREZZA may
bring to patients. 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 commercialization of INGREZZA; risks that clinical trial
activities may not be predictive of real-world results or of
results in subsequent clinical trials; risks that INGREZZA may be
precluded from commercialization by the proprietary rights of third
parties, or have unintended side effects or adverse reactions;
risks and uncertainties relating to competitive products and
technological changes that may limit demand for INGREZZA; risks
associated with our dependence on third parties for development and
manufacturing activities related to INGREZZA and our product
candidates, and our ability to manage these third parties; risks
that the FDA or other regulatory authorities may make adverse
decisions regarding our products or product candidates; risks that
our products, and/or our product candidates may be precluded from
commercialization by the proprietary or regulatory rights of third
parties, or have unintended side effects, adverse reactions or
incidents of misuse; risks associated with potential generic
entrants for our products; 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, 2023. Neurocrine Biosciences disclaims
any obligation to update the statements contained in this press
release after the date hereof.
©2023 Neurocrine Biosciences, Inc. All Rights Reserved.
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