SAN
DIEGO, June 2, 2023 /PRNewswire/
-- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today presented
findings from a meta-analysis of three long-term studies evaluating
INGREZZA® (valbenazine) capsules that demonstrated
substantial and sustained improvements in tardive dyskinesia (TD)
in adults with or without concomitant antipsychotic therapy. The
data (Poster #4) were presented at 2023 Psych Congress
Elevate in Las Vegas.
The analysis of the three studies (KINECT™ 3,
KINECT™ 4, and
J-KINECT™) demonstrated that treatment with
once-daily INGREZZA (40 mg or 80 mg) resulted in substantial and
sustained TD improvement through week 48 as measured by the
Abnormal Involuntary Movement Scale (AIMS) total score, with no
meaningful differences between study completers taking
antipsychotics at baseline (AP+) and those who were not (AP-).
Upon withdrawal of INGREZZA, both subgroups experienced a return
toward baseline severity of TD symptoms, demonstrating the
potentially persistent nature of TD, even in patients no longer
taking antipsychotic therapy. Researchers concluded that
continuous treatment with INGREZZA to manage TD may be warranted
irrespective if they were on concurrent antipsychotic therapy.
"TD may persist even after patients are no longer taking
antipsychotic therapy," said Eiry W. Roberts, M.D., Chief
Medical Officer at Neurocrine Biosciences. "These data from three
long-term studies reinforce the continuing value of INGREZZA in TD
management, regardless of antipsychotic status."
Key results from the meta-analysis demonstrated the
following:
- Mean baseline AIMS scores within each study ranged from 7.9 to
14.9 in the subgroup taking antipsychotics at baseline (AP+) and
from 10.9 to 14.5 in the subgroup not taking antipsychotics at
baseline (AP-)
- Mean changes from baseline in AIMS total scores within the
combined group were similar between the AP+ and AP- subgroups and
indicated substantial TD improvements with INGREZZA 40 mg and 80 mg
at week 48 (AP+, -6.1; AP-, -6.5)
- Both AP+ and AP- subgroups within the combined group
experienced a return toward baseline severity at week 52, four
weeks after INGREZZA 40 mg or 80 mg withdrawal (AP+, -2.1; AP-,
-1.4)
Additional presentations include:
- Global Improvements and Psychiatric Stability in Adults With
Tardive Dyskinesia and Mood Disorder: Post Hoc Analyses of Two
Long-Term Valbenazine Studies (Poster #3)
The full abstracts presented by Neurocrine Biosciences at 2023
Psych Congress Elevate are available on the meeting website and can
be accessed by registering.
About the KINECT™ 3 Phase 3 Study
KINECT 3
is a Phase 3, randomized, double-blind, placebo-controlled,
parallel-group, fixed-dose study, in which 234 participants with
moderate to severe TD and underlying schizophrenia, schizoaffective
disorder or mood disorder (including bipolar disorder or major
depressive disorder) received six weeks of once-daily INGREZZA (40
mg or 80 mg capsules) or placebo (participants randomized to 80 mg
started on 40 mg for one week). Subsequent to the completion of the
six-week placebo-controlled dosing, participants receiving INGREZZA
continued on their current dose, and placebo participants were
randomized to receive either once-daily 40 mg or once-daily 80 mg
of INGREZZA, through week 48 (42-week blinded treatment extension
period; placebo participants randomized to 80 mg started on 40 mg
for one week), followed by a four-week drug-free washout. Dose
reduction to 40 mg was allowed for participants who were unable to
tolerate the 80 mg dose. Patients were discontinued if the new dose
was not tolerated.
The study met its primary endpoint of change-from-baseline in
AIMS at week six in the 80 mg once-daily dosing group compared to
placebo, as assessed by expert central blinded video raters. The
mean change from baseline to week six in the AIMS rating was -3.2
for the 80 mg once-daily group as compared to -0.1 in the placebo
group (P>0.0001). Sustained TD improvements were seen
with INGREZZA 40 mg and 80 mg through week 48.
INGREZZA was generally well tolerated throughout 48 weeks of
treatment. The most common adverse reactions (≥ five percent and
twice the rate of placebo) during the six-week, double-blind,
placebo-controlled phase was somnolence with the frequency of
adverse events being similar among all treatment groups.
Treatment-emergent adverse events (TEAEs) were consistent with
those of prior studies. There were no drug-drug interactions
identified in participants who were utilizing a wide range of
psychotropic and other concomitant medications, and participants
generally remained psychiatrically stable throughout the study.
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 four, 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 J-KINECT™ Phase 2 and 3 Studies
In
2015, Mitsubishi Tanabe Pharma Corporation (MTPC) exclusively
licensed the development and commercialization rights for
valbenazine in Japan and certain
other Asian countries with Neurocrine Biosciences. MTPC conducted
J-KINECT, the Phase 2/3, multicenter, randomized, double-blind,
placebo-controlled study to confirm the efficacy and safety of
valbenazine 40 mg or 80 mg administered once daily for up to 48
weeks in adult patients with moderate or severe tardive dyskinesia
(TD). The study showed a significant improvement in the primary
efficacy endpoint of the mean change from baseline in the Abnormal
Involuntary Movement Rating Scale (AIMS) total score at week 6 of
treatment with valbenazine compared to placebo. The persistence of
efficacy was also shown in the AIMS total score at week 48. In
addition, valbenazine was also well tolerated. The incidence of
adverse events was highest in the 80 mg group and included
nasopharyngitis, somnolence, schizophrenia worsening,
hypersalivation, insomnia and tremor. In 2021, MTPC received
approval of valbenazine capsules 40mg for the treatment of TD in
Singapore, Thailand, South
Korea, and Indonesia,
followed by approval in Japan and
Malaysia in 2022.
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 U.S.
About INGREZZA® (valbenazine) Capsules
INGREZZA, a selective vesicular monoamine transporter 2 (VMAT2)
inhibitor, is an FDA-approved product indicated for the treatment
of adults with tardive dyskinesia, a condition associated with
uncontrollable, abnormal, and repetitive movements of the face,
torso, and/or other body parts.
INGREZZA is thought to work by reducing the amount of dopamine
released in a region of the brain that controls movement and motor
function, helping to regulate nerve signaling in adults with
tardive dyskinesia. VMAT2 is a protein in the brain that packages
neurotransmitters, such as dopamine, for transport and release in
presynaptic neurons. INGREZZA, developed by Neurocrine Biosciences,
is novel in that it selectively inhibits VMAT2 with no appreciable
binding affinity for VMAT1, dopaminergic (including D2),
serotonergic, adrenergic, histaminergic, or muscarinic receptors.
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 Use
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).
It is not known if INGREZZA is safe and effective in
children.
IMPORTANT SAFETY INFORMATION
Do not take INGREZZA if you:
- are allergic to valbenazine, or any of the ingredients in
INGREZZA.
INGREZZA may cause serious side effects,
including:
- Sleepiness (somnolence). Do not drive, operate heavy
machinery, or do other dangerous activities until you know how
INGREZZA affects you.
- 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
- shortness of breath
- dizziness or fainting
Tell your healthcare provider right away if
you have a change in your heartbeat (a fast or irregular
heartbeat), or if you faint.
- 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.
The most common side effect of INGREZZA is sleepiness
(somnolence). Other side effects include changes in balance
(balance problems, dizziness) or an increased risk of falls,
headache, feelings of restlessness, dry mouth, constipation, and
blurred vision.
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 accompanying INGREZZA full Product
Information.
About Neurocrine Biosciences
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,
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 logo, 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 March 31, 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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SOURCE Neurocrine Biosciences, Inc.