SAN DIEGO, March 21, 2017 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX), a biotechnology company focused
on neurologic, psychiatric and endocrine related disorders,
announced today that positive results from the Kinect 3 Phase III
study of INGREZZA (valbenazine) for the treatment of tardive
dyskinesia (TD) were published online by the American Journal of
Psychiatry (DOI: 10.1176/appi.ajp.2017.16091037). Once-daily
INGREZZA, a novel, selective vesicular monoamine transporter 2
(VMAT2) inhibitor, demonstrated a significant and meaningful
reduction in TD symptoms compared with placebo in participants with
underlying schizophrenia, schizoaffective disorder or mood
disorder. INGREZZA was found to be generally well tolerated with
adverse events consistent with those of prior studies.
Tardive dyskinesia is thought to affect at least 500,000 people
in the U.S. and is characterized by uncontrollable, abnormal
and repetitive movements of the trunk, extremities and/or
face. These symptoms are associated with chronic exposure to
dopamine receptor blockers such as antipsychotic medications and
can be severe, persistent and irreversible. In some cases, they can
even interfere with speech, walking, swallowing and breathing.
"The unprecedented results from the Kinect 3 study demonstrate
the potential of INGREZZA to fill a significant unmet need in this
underserved patient population," said Kevin
C. Gorman, Chief Executive Officer of Neurocrine. "This
novel, new chemical entity was developed by Neurocrine chemists and
biologists who devoted themselves to identifying a treatment for
those living with the disruptive impact of tardive
dyskinesia."
"There are currently no medications indicated for the treatment
of tardive dyskinesia approved by the U.S. Food and Drug
Administration. A common approach to address the condition has been
to discontinue antipsychotic treatment or reduce the dosage, which
may often have a negative impact on the psychiatric status of
individuals suffering from TD," said Christopher F. O'Brien, Chief Medical Officer of
Neurocrine. "The results of the Kinect 3 study indicate that
INGREZZA significantly reduced tardive dyskinesia symptoms while
maintaining stability of psychiatric status during treatment."
Neurocrine has submitted a New Drug Application (NDA) to the
U.S. Food and Drug Administration (FDA) for INGREZZA and has been
granted Priority Review with a Prescription Drug User Fee Act
(PDUFA) action date of April 11,
2017. Neurocrine received Breakthrough Therapy Designation
from the FDA in 2014 for INGREZZA for the treatment of TD.
Kinect 3 Study Results
The study met its primary endpoint of change-from-baseline in
the Abnormal Involuntary Movement Scale (AIMS) at week six in the
80mg 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 80mg once-daily
group as compared to -0.1 in the placebo group (p>0.0001).
In addition, the percentage of participants who achieved an AIMS
response (defined in the study as a reduction greater than or equal
to 50 percent from baseline in dyskinesia score) was higher in the
INGREZZA 80mg/day group compared to placebo at all study visits. At
week six, 40 percent (p<0.001) of participants receiving
80mg/day of INGREZZA had at least a 50% improvement in AIMS
dyskinesia score as compared to only 8.7 percent of those who
received placebo.
The Kinect 3 study was a Phase III, randomized, double-blind,
placebo-controlled, parallel-group, fixed-dose study in which 234
subjects with TD and underlying schizophrenia, schizoaffective
disorder or mood disorder (including bipolar disorder or major
depressive disorder) receive six weeks of once-daily INGREZZA (40mg
or 80mg capsules) or placebo. Subsequent to the completion of
the six week placebo-controlled dosing, all subjects were placed on
once-daily 40mg or once-daily 80mg of INGREZZA through week 48.
Safety Profile
During the six-week placebo-controlled treatment period INGREZZA
was generally well tolerated and the most common adverse reactions
were somnolence and drooling. The frequency of adverse events was
similar among all treatment groups and treatment emergent adverse
effects were consistent with those of prior studies. There
were no drug-drug interactions identified in subjects who were
utilizing a wide range of psychotropic and other concomitant
medications.
About Tardive Dyskinesia
Tardive dyskinesia is caused by treatments that block dopamine
receptors in the brain, such as antipsychotics and other
medications. In patients with TD, these treatments are thought to
result in excessive dopamine signaling in the region of the brain
that controls movement. Tardive dyskinesia is characterized by
uncontrollable, abnormal and repetitive movements of the trunk,
extremities and/or face. These can include hand or foot movements,
rocking of the trunk, lip smacking, grimacing, tongue protrusion,
facial movements or blinking, as well as puckering and pursing of
the lips. Tardive dyskinesia can cause significant impairment
and may lead to social withdrawal, reduced workplace productivity
or loss of employment, feeling embarrassed in public, or
making others feel uncomfortable.
About INGREZZA
VMAT2 is a protein concentrated in the human brain that is
primarily responsible for re-packaging and transporting monoamines
(dopamine, norepinephrine, serotonin, and histamine) in
pre-synaptic neurons. INGREZZA (valbenazine) capsules, developed in
the Neurocrine laboratories, is a novel, selective VMAT2 inhibitor
that modulates dopamine release during nerve communication, showing
little or no affinity for VMAT1, other receptors, transporters and
ion channels. INGREZZA is designed to provide low, sustained,
plasma and brain concentrations of active drug to allow for
once-daily dosing. The proprietary name INGREZZA has been
conditionally accepted by the FDA.
Modulation of neuronal dopamine levels in diseases such as
tardive dyskinesia, Tourette syndrome, Huntington's chorea,
schizophrenia, and tardive dystonia, which are characterized, in
part, by a hyperdopaminergic state, may provide symptomatic
benefits for patients with these diseases.
The Company has a pending NDA under review by the FDA to utilize
INGREZZA for the treatment of tardive dyskinesia. The Company also
has another ongoing placebo-controlled Phase II Tourette syndrome
study evaluating INGREZZA in pediatrics, the T-Force GREEN study.
Additionally, the Company has an ongoing open-label, fixed-dose
rollover study of INGREZZA in up to 180 subjects with Tourette
syndrome.
About Neurocrine Biosciences
Neurocrine Biosciences, Inc. discovers and develops innovative
and life-changing pharmaceuticals in diseases with high unmet
medical needs through its novel R&D platform, focused on
neurologic, psychiatric and endocrine based diseases and disorders.
The Company's three late-stage clinical programs are: INGREZZA, a
VMAT2 inhibitor for the treatment of movement disorders; elagolix,
a gonadotropin-releasing hormone antagonist for women's health that
is partnered with AbbVie Inc.; and opicapone, a novel, once-daily,
peripherally-acting, highly-selective catechol-o-methyltransferase
inhibitor under investigation as adjunct therapy to levodopa in
Parkinson's patients. Neurocrine plans to commercialize INGREZZA in
the United States upon approval by
the FDA.
Neurocrine Biosciences, Inc. news releases are available through
the Company's website via the internet at
http://www.neurocrine.com.
Forward Looking Statements
In addition to historical facts, this press release contains
forward-looking statements that involve a number of risks and
uncertainties. 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's
business and finances in general, as well as risks and
uncertainties associated with INGREZZA development for both tardive
dyskinesia and/or Tourette syndrome. Specifically, the risks and
uncertainties the Company faces include risks that the INGREZZA NDA
may not obtain regulatory approval from the FDA for tardive
dyskinesia or such approval may be delayed or conditioned; risks
that additional regulatory submissions, for Tourette syndrome or
otherwise, may not occur or be submitted in a timely manner; risks
that the FDA or regulatory authorities outside the U.S. may make
adverse decisions regarding INGREZZA; risks that INGREZZA
development activities may not be completed on time or at all;
risks that ongoing INGREZZA development activities may be delayed
for regulatory or other reasons; risks that ongoing or future
INGREZZA clinical trials may not be successful or replicate
previous clinical trial results, may fail to demonstrate that
INGREZZA is safe, tolerable or effective, or 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, adverse reactions or incidents of misuse; risks associated
with the Company's dependence on third parties for development and
manufacturing activities related to INGREZZA; risks that the
Company will be unable to raise additional funding, if required, to
complete development of or commercialize INGREZZA; risks and
uncertainties relating to competitive products and technological
changes that may limit demand for INGREZZA; risks that the Company
may not successfully commercialize INGREZZA; and other risks
described in the Company's annual report on Form 10-K for the year
ended December 31, 2016. Neurocrine
disclaims any obligation to update the statements contained in this
press release after the date hereof.
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SOURCE Neurocrine Biosciences, Inc.