SAN
DIEGO, Nov. 4, 2024 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (Nasdaq: NBIX) presented data from the
long-term KINECT®-4 study demonstrating tardive
dyskinesia remission in nearly 60% of participants at Week 48 with
once-daily INGREZZA® (valbenazine) capsules treatment.
This research, "Remission of Tardive Dyskinesia in Patients
Receiving Long-Term Valbenazine Treatment" (Poster #98), was shared
at the 2024 Psych Congress in Boston.
"Tardive dyskinesia is persistent and irreversible, and
effective treatment over time can have a positive impact for
patients who are already living with underlying psychotic and mood
disorders," said Eiry W. Roberts, M.D., Chief Medical
Officer, Neurocrine Biosciences. "Our clinical studies have
shown clinically meaningful and sustained improvement in tardive
dyskinesia with INGREZZA, and these remission data add to the body
of evidence characterizing the robust impact of INGREZZA
treatment."
This post hoc analysis was conducted using data from 103
participants who reached the final Week 48 visit in the open-label
KINECT-4 clinical trial.
Remission was defined as having a score of 1 or less (rating of
"none" or "minimal") in each body region (items 1-7) on the
Abnormal Involuntary Movement Scale (AIMS). Shifts to remission
were defined as a maximum item score of 2 ("mild"), 3 ("moderate")
or 4 ("severe") at baseline and each item score of 1 or less at
Week 48.
Treatment with INGREZZA resulted in tardive dyskinesia
(TD) symptom remission for the majority of patients at Week
48:
- 59.2% (61/103) of participants had a score of 1 or less in each
AIMS item.
- 65.0% (13/20) of participants in the 40 mg dose group and 57.8%
(48/83) of participants in the 80 mg dose group met this remission
threshold.
- 10% (10/103) of participants had complete resolution, with a
total AIMS score of 0.
- Of the 4 participants with a maximum item score of 2 at
baseline, 50.0% (2/4) reached the remission threshold.
- Of the 56 participants with a maximum item score of 3 at
baseline, 64.3% (36/56) reached the remission threshold.
- Of the 43 participants with a maximum item score of 4 at
baseline, 53.5% (23/43) reached the remission threshold.
Additional Neurocrine Biosciences posters presented at Psych
Congress 2024 include:
- Once-Daily Valbenazine for Tardive Dyskinesia or Huntington's Disease Chorea in Patients with
Dysphagia or Swallowing Difficulties (Poster #114)
- A Multi-Year Survey on United States Psychiatry Clinicians:
Trends on Managing Patients with Tardive Dyskinesia (Poster
#48)
- Item Response Theory (IRT) Analyses of the Tardive Dyskinesia
Impact Scale (TDIS) (Poster #28)
- Impact of Valbenazine on Physical, Psychological, and
Functional Health in Patients with Tardive Dyskinesia: Results of
EQ-5D-5L Health State Scores from 16 Weeks of Valbenazine
Treatment (Poster #29)
- Real World Improvement in Quality of Life and Functional Status
of Valbenazine-Treated Patients With Tardive Dyskinesia From a 2024
Chart Extraction and Clinician Survey of 164 Patients (Poster
#27)
- Treatment Effect Sizes of Once-Daily Valbenazine for Tardive
Dyskinesia and for Chorea Associated with Huntington's Disease: A Post Hoc Analysis of
Phase 3 Clinical Trial Data (Poster #44)
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 800,000
people in the U.S.
About Chorea Associated with Huntington's Disease
(HD)
Huntington's disease
(HD) is a hereditary progressive neurodegenerative disorder in
which the loss of certain neurons within the brain causes motor,
cognitive and psychiatric symptoms. Symptoms generally appear
between the ages of 30 and 50 years and worsen over a 10- to
25-year period. Most people with HD experience chorea, an abnormal
involuntary movement disorder, characterized by irregular and
unpredictable movements. Chorea can affect various body parts and
interfere with motor coordination, gait, swallowing and speech. HD
is estimated to affect approximately 41,000 adults in
the U.S., with more than 200,000 at risk of inheriting the
disease.
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 effect 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. 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; risks that clinical trial activities
may not be predictive of real-world results or of results in
subsequent clinical trials; 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, manufacturing, and commercialization
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 September 30, 2024. Neurocrine
Biosciences disclaims any obligation to update the statements
contained in this press release after the date hereof other than
required by law.
© 2024 Neurocrine Biosciences, Inc. All Rights Reserved
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