SAN
DIEGO, Feb. 27, 2025 /PRNewswire/
-- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced
top-line data from a Phase 4 study, KINECT-PRO™, demonstrating
clinically meaningful and sustained effects of INGREZZA®
(valbenazine) capsules on the physical, social and emotional
impacts experienced by patients living with tardive dyskinesia
(TD), irrespective of TD severity or underlying psychiatric
condition. KINECT-PRO is the first study to show patient-reported
impact of a vesicular monoamine transporter 2 inhibitor,
specifically INGREZZA, on TD using multiple clinically validated
scales, including the Tardive Dyskinesia Impact Scale used to
evaluate the physical, social and emotional impact of involuntary
movements. These patient-reported outcome measures provide a more
complete perspective on a patient's experience of living with TD
and the broad range of improvements that occurred following
treatment with INGREZZA. The results of KINECT-PRO will be shared
at upcoming scientific conferences.
"Tardive dyskinesia can significantly impact many aspects of
patients' lives, including daily activities, work or school
attendance and social interactions," said Eiry W. Roberts, M.D.,
Chief Medical Officer, Neurocrine Biosciences. "The data from the
KINECT-PRO trial, which was designed to follow typical clinical
practice, show that patients and clinicians observed substantial
reduction in the impact and severity of TD, as well as improvement
in overall quality of life with use of INGREZZA. Importantly,
patients reported significant improvements across measures
regardless of their underlying psychiatric conditions or the
baseline severity of their TD involuntary movement symptoms."
Fifty-nine patients were enrolled in the KINECT-PRO study and
received once-daily INGREZZA (40 mg, 60 mg or 80 mg) for up to 24
weeks. Fifty-two patients completed the Week 24 visit. There were
comparable numbers of patients across TD severity (mild vs.
moderate/severe) and underlying psychiatric condition subgroups
(schizophrenia or schizoaffective disorder vs. bipolar disorder or
major depression).
The primary objective of the KINECT-PRO study was to evaluate
changes in patient-reported physical and socio-emotional impacts of
TD, changes in a person's work, family, social life and overall
sense of health and well-being during INGREZZA treatment. These
outcomes were measured at Weeks 4, 8, 16 and 24 by the Tardive
Dyskinesia Impact Scale (TDIS), the Sheehan Disability Scale (SDS)
and the EQ Visual Analogue Scale (EQ-VAS), respectively. The
secondary objective was to evaluate clinician- and patient-reported
changes in TD severity as measured by the Abnormal Involuntary
Movement Scale (AIMS), the Patient Global Impression of Change–TD
(PGI-C) and Clinical Global Impression of Severity–TD
(CGI-TD-S).
Results showed significant and sustained improvements from
baseline in all three patient-reported outcome measures, including
patients with either mild or moderate/severe TD, with improvements
observed as early as four weeks at the lowest dose (40 mg). AIMS
scores also showed sustained reductions in involuntary movements,
regardless of TD severity or underlying psychiatric condition. In
the study, safety and tolerability of treatment was consistent with
the known profile of INGREZZA, with no new concerns identified.
About the KINECT-PRO™ Phase 4 Study
The KINECT-PRO™
Phase 4, open-label study was designed to evaluate patient reported
outcomes on the use of INGREZZA® (valbenazine) capsules
in a tardive dyskinesia (TD) patient population reflective of
real-world clinical practice. Participants had at least mild TD,
were aware of and experiencing at least mild distress from their
abnormal, involuntary movements and had a clinical diagnosis of
schizophrenia, schizoaffective disorder, bipolar disorder or major
depression. The KINECT-PRO study included a four-week screening
period, a 24-week treatment period during which participants
received 40 mg of INGREZZA once-daily for the first four weeks,
followed by flexible dosing of 40 mg, 60 mg or 80 mg once-daily
based on individual treatment needs and a two-week safety follow-up
period. Baseline socio-demographic and clinical characteristics of
the participants were broadly similar to those of the
KINECT®-3 and KINECT®-4 studies.
About the Tardive Dyskinesia Impact Scale (TDIS)
The
Tardive Dyskinesia Impact Scale (TDIS) is a novel, psychometrically
validated patient-reported outcome measure in TD. It was developed
by Neurocrine Biosciences from qualitative studies and Phase 3
trials of INGREZZA for the treatment of TD (KINECT®-3
and KINECT®-4) as a comprehensive measure of impact and
burden of TD from a patient's perspective. The TDIS consists of 11
questions evaluating physical and socio-emotional impact. Six
domains are assessed: mouth/throat, dexterity, mobility, pain,
social and emotional. The TDIS allows people with TD to rate how
their symptoms affect daily activities and how their uncontrollable
movements make them feel. The questionnaire captures relevant
information about the impact of TD to provide a more holistic
assessment of the condition. Validation of this scale was published
in the Journal of Patient-Reported Outcomes.
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 (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 at least 800,000 adults
in the U.S.
About INGREZZA® (valbenazine) Capsules
and INGREZZA® SPRINKLE (valbenazine)
Capsules
INGREZZA is a 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). Only INGREZZA offers a therapeutic dose from day one
with no required titration.
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 TD and HD chorea is not fully understood,
INGREZZA is unique in that it selectively and specifically 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.
INGREZZA is always one capsule, once daily and can be taken
together with most stable mental health regimens such as
antipsychotics or antidepressants. Only INGREZZA offers the benefit
of a sprinkle formulation, INGREZZA® SPRINKLE, for
those who experience dysphagia, have difficulty swallowing or
prefer not to swallow a pill. INGREZZA and INGREZZA SPRINKLE
dosages approved for use are 40 mg, 60 mg and 80 mg
capsules.
Important Information
Approved Uses
INGREZZA® (valbenazine) capsules or
INGREZZA® SPRINKLE (valbenazine) capsules are
prescription medicines 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 or INGREZZA SPRINKLE do not cure the cause of involuntary
movements, and do not treat other symptoms of Huntington's disease,
such as problems with thinking or emotions.
It is not known if INGREZZA or INGREZZA SPRINKLE is safe and
effective in children.
IMPORTANT SAFETY INFORMATION
INGREZZA or INGREZZA SPRINKLE 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 or INGREZZA
SPRINKLE 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 or INGREZZA
SPRINKLE 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 or INGREZZA SPRINKLE if you:
- are allergic to valbenazine, or any of the ingredients in
INGREZZA or INGREZZA SPRINKLE.
INGREZZA or INGREZZA SPRINKLE can cause serious side effects,
including:
- Allergic reactions. Allergic reactions, including
an allergic reaction that causes sudden swelling called angioedema
can happen after taking the first dose or after many doses of
INGREZZA or INGREZZA SPRINKLE. Signs and symptoms of allergic
reactions and angioedema include: trouble breathing or shortness of
breath, swelling of your face, lips, eyelids, tongue, or throat, or
other areas of your skin, trouble with swallowing, or rash,
including raised, itchy red areas on your skin (hives). Swelling in
the throat can be life-threatening and can lead to death. Stop
taking INGREZZA or INGREZZA SPRINKLE and go to the nearest
emergency room right away if you develop these signs and symptoms
of allergic reactions and angioedema.
- Sleepiness and tiredness that could cause slow reaction
times (somnolence and sedation). Do not drive a car or
operate dangerous machinery until you know how INGREZZA or INGREZZA
SPRINKLE affects you. Drinking alcohol and taking other medicines
may also cause sleepiness during treatment with INGREZZA or
INGREZZA SPRINKLE.
- Heart rhythm problems (QT prolongation). INGREZZA
or INGREZZA SPRINKLE may cause a heart rhythm problem known as QT
prolongation. You have a higher chance of getting QT prolongation
if you also take certain other medicines during treatment with
INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider right
away if you develop any signs or symptoms of QT prolongation,
including: fast, slow, or irregular heartbeat (heart palpitations),
shortness of breath, dizziness or lightheadedness, or fainting or
feeling like you are going to 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, irregular pulse or
blood pressure, increased sweating, or very fast or uneven
heartbeat.
- Parkinson-like symptoms. Symptoms include: body
stiffness, drooling, trouble moving or walking, trouble keeping
your balance, shaking (tremors), or falls.
Before taking INGREZZA or INGREZZA SPRINKLE, 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. Make sure you tell all
of your healthcare providers that you are taking INGREZZA or
INGREZZA SPRINKLE. Taking INGREZZA or INGREZZA SPRINKLE with
certain other medicines may cause serious side effects. Especially
tell your healthcare provider if you: take digoxin or take or have
taken a monoamine oxidase inhibitor (MAOI) medicine. You should not
take INGREZZA or INGREZZA SPRINKLE if you are taking, or have
stopped taking, a MAOI within the last 14 days.
The most common side effects of INGREZZA or INGREZZA SPRINKLE
in people with tardive
dyskinesia are sleepiness and tiredness.
The most common side effects of INGREZZA or INGREZZA SPRINKLE
in people with chorea associated with Huntington's disease
include sleepiness and tiredness, raised itchy red areas
on your skin (hives), rash, and trouble getting to sleep or staying
asleep.
These are not all of the possible side effects of INGREZZA or
INGREZZA SPRINKLE. 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.
Dosage Forms and Strengths: INGREZZA and INGREZZA
SPRINKLE are available in 40 mg, 60 mg, and 80 mg
capsules.
Please see full Prescribing Information, including Boxed
Warning, and Medication Guide.
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. 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, classic congenital adrenal
hyperplasia, 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 LinkedIn, X and Facebook. (*in
collaboration with AbbVie)
The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE
SCIENCE, 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. Factors that
could cause actual results to differ materially from those stated
or implied in the forward-looking statements include, but are not
limited to, the following: risks and uncertainties associated
with Neurocrine Biosciences' business and finances in
general, as well as risks and uncertainties associated with the
commercialization of INGREZZA; whether INGREZZA receives adequate
reimbursement from third-party payors; risks and uncertainties
relating to competitive products and technological changes that may
limit demand for INGREZZA; risks associated with the Company's
dependence on third parties for development and manufacturing
activities related to INGREZZA, and the ability of the Company to
manage these third parties; risks that additional regulatory
submissions for INGREZZA 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
INGREZZA; risks that post-approval INGREZZA commitments or
requirements may be delayed; risks that INGREZZA 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; and other risks described in the Company's
periodic reports filed with the Securities and Exchange
Commission, including without limitation the Company's annual
report on Form 10-K for the year ended December 31,
2024. Neurocrine Biosciences disclaims any obligation to
update the statements contained in this press release after the
date hereof other than required by law.
© 2025 Neurocrine Biosciences, Inc. All Rights Reserved.
CAP-VBZ-US-0047 02/2025
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