SAN
DIEGO, May 21, 2024 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (Nasdaq: NBIX) today announced the
publication of data from a post hoc analysis of the Phase 3
KINECT®-4 study of INGREZZA® (valbenazine)
capsules in the Journal of Clinical
Psychopharmacology. The analysis assessed long-term
outcomes relevant to the real-world management of tardive
dyskinesia (TD) and demonstrated that nearly all study participants
met the threshold for clinically meaningful improvements in TD
symptom severity by Week 48.
"TD is a persistent, debilitating disorder requiring continuous
treatment to effectively and sustainably improve symptoms over
time," said Eiry W. Roberts, M.D., Chief Medical Officer at
Neurocrine Biosciences. "This post hoc analysis, along with
previous long-term analyses, demonstrate the reliable, long-term
efficacy and tolerability of one-capsule, once-daily INGREZZA to
help inform use of this treatment in clinical practice."
The KINECT-4 study implemented an open-label design and on-site
assessments of TD severity. The analysis included 103 participants
from the Phase 3 KINECT-4 study who completed 48 weeks of treatment
with INGREZZA. KINECT-4 was designed to be representative of
clinical practice to provide insight into real-world management of
TD with INGREZZA.
Key highlights include:
- At Week 4, 55% of participants experienced clinically
meaningful improvement in TD symptom severity on the lowest
starting dose (40 mg). A clinically meaningful improvement was
defined as a reduction of at least 2 points in the Abnormal
Involuntary Movement Scale (AIMS) total score used to assess the
severity of involuntary movements in different body regions.
Ninety-five percent of participants reached this threshold as soon
as Week 24, with 97% achieving it by Week 48. TD improvement was
sustained throughout treatment, with an AIMS mean total score
reduction from baseline to Week 48 of 10.5.
- Eighty-six percent of participants met the response threshold
of at least 50% AIMS improvement, and 52% met the higher threshold
of at least 70% AIMS improvement at Week 48.
- More than 88% of patients and healthcare professionals rated
participants' symptoms as "much improved" or "very much improved"
at Week 48, as measured by the Patient Global Impression of Change
and Clinical Global Impression of Change-TD, respectively.
Overall, INGREZZA was generally well tolerated. The most common
treatment emergent adverse events reported from Weeks 4 to 48
included urinary tract infection (8.5%) and headache (5.2%).
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% of all participants (combined dose groups) were urinary tract
infection (8.5%) and headache (5.2%). 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 (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 TD and 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 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 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
VMAT2 inhibitors, including INGREZZA and 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, 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, 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, X
(formerly Twitter) and Facebook. (*in collaboration with
AbbVie)
The NEUROCRINE BIOSCIENCES Logo Lockup, 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. 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 Neurocrine Biosciences' business and finances in general, as
well as 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 March 31, 2024.
Neurocrine Biosciences disclaims any obligation to update the
statements contained in this press release after the date
hereof.
Reference:
- Correll CU, Citrome L, Singer C, Lindenmayer JP, Zinger C,
Liang G, Dunayevich E, Marder SR. Sustained treatment response and
global improvements with long-term valbenazine in patients with
tardive dyskinesia. J Clin Psychopharmacology. May 20, 2024.
doi:10.1097/JCP.0000000000001860
© 2024 Neurocrine Biosciences, Inc. All Rights Reserved.
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