SAN DIEGO, April 11, 2017 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX) announced today that the U.S. Food
and Drug Administration (FDA) has approved INGREZZA™
(valbenazine) capsules for the treatment of adults with tardive
dyskinesia (TD). INGREZZA, a novel, selective vesicular monoamine
transporter 2 (VMAT2) inhibitor, is the first and only FDA-approved
product indicated for the treatment of adults with TD.
Experience the interactive Multimedia News Release here:
https://www.multivu.com/players/English/8074551-neurocrine-ingrezza-valbenazine-fda-approval
"The often debilitating effects of tardive dyskinesia have left
people feeling isolated and forgotten. The approval of INGREZZA
represents a turning point for these patients and their care
partners, offering a meaningful treatment where before there was
little hope," said Kevin C. Gorman,
Chief Executive Officer of Neurocrine Biosciences. "For the past 20
years, Neurocrine has been devoted to developing treatments for
difficult to manage conditions in underserved patient populations.
We are committed to ensuring that those impacted by the disruptive
effects of TD have access to INGREZZA."
"Until now, one of the few options for physicians, when managing
TD, was to stop, change or lower the dose of antipsychotic
medication, potentially jeopardizing patients' psychiatric
stability," said Christoph U.
Correll, MD, Professor, Psychiatry and Molecular Medicine,
Hofstra Northwell School of Medicine. "In clinical trials, INGREZZA
significantly and rapidly improved TD symptoms compared to placebo,
reducing involuntary movements acutely and through 48 weeks of
treatment without compromising underlying psychiatric care. These
results, combined with convenient once-daily dosing, represent a
tremendous breakthrough for patients suffering from TD."
Clinical studies have shown that INGREZZA provides significant,
rapid and meaningful improvement in TD signs and symptoms compared
to placebo through six weeks, with continued reductions in TD
observed through 48 weeks of treatment. INGREZZA was generally well
tolerated, with somnolence as the only adverse event occurring at a
rate greater than or equal to 5 percent and twice placebo. In
clinical trials, no worsening in safety scale scores for
depression, suicidal ideation or behaviors was observed. INGREZZA
has been studied in over 1,000 individuals and more than 20
clinical trials.
"A treatment for tardive dyskinesia is a welcome and exciting
step in the continued effort to destigmatize mental health
conditions," said Paul Gionfriddo,
President & CEO of Mental Health America. "With an FDA approved
treatment now available, individuals and doctors can have more
productive and proactive conversations about TD."
"The FDA's approval of INGREZZA represents the culmination of
over ten years of dedicated effort from the Neurocrine research and
development teams," said Christopher F.
O'Brien, MD, Neurocrine's Chief Medical Officer. "Neurocrine
would like to thank the many clinical investigators and TD patients
who participated in our clinical trials. Without their partnership
and commitment, we would not have been able to achieve this
tremendous breakthrough."
INGREZZA will be in the distribution channel next week and will
be available through a select pharmacy network. Promotion to
healthcare professionals will commence on May 1, 2017. To assist TD patients in gaining
access to INGREZZA, Neurocrine has created the INBRACETM
patient support program, which will immediately begin accepting
treatment initiation forms from health care professionals
prescribing INGREZZA and work closely with patients and their
families to facilitate access. INBRACE is designed to provide
personalized product assistance and services. For more information,
patients may visit www.INGREZZA.com or call 1-84-INGREZZA
(1-844-647-3992).
Conference Call
Neurocrine will hold a live conference call today at
5:30pm ET (2:30pm PT). Participants can access the live
conference call by dialing 866-610-1072 (US) or 973-935-2840
(International) using the conference ID 99380770. The call and
slide presentation can also be accessed via webcast through the
Company's website at www.neurocrine.com.
If you are unable to attend the webcast and would like further
information on this announcement, please contact the Investor
Relations Department at Neurocrine Biosciences at (858)
617-7600. A replay of the conference call will be available
approximately one hour after the conclusion of the call by dialing
800-585-8367 (US) or 404-537-3406 (International) using the
conference ID 99380770. The call will be archived for approximately
two weeks.
About Tardive Dyskinesia (TD)
TD is characterized by uncontrollable, abnormal and repetitive
movements of the trunk, extremities and/or face. The condition is
caused by treatments that block dopamine receptors in the brain,
such as antipsychotics and other medications, which are commonly
prescribed to treat mental illnesses such as schizophrenia, bipolar
disorder and depression. 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 500,000 people in the U.S.
About INGREZZA
INGREZZA, a selective VMAT2 inhibitor, is the first and only
product indicated for the treatment of adults with tardive
dyskinesia. The approval of INGREZZA was based on data from
the Kinect 3 study, a Phase III, randomized, double-blind,
placebo-controlled, parallel-group, fixed-dose study comparing
once-daily INGREZZA 80mg and 40mg to placebo over six weeks in
patients with underlying schizophrenia, schizoaffective disorder or
mood disorder. 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. INGREZZA met
the primary endpoint in this study with a mean change from baseline
to week six in the AIMS dyskinesia total score of -3.2 for the 80mg
once-daily group as compared to -0.1 in the placebo group
(p<0.0001). Also in the Kinect 3 study:
- The percentage of participants who achieved at least a 50%
reduction in AIMS was 40 percent (p<0.001) in participants
receiving 80mg/day of INGREZZA compared to only 8.7 percent of
those who received placebo.
- INGREZZA was found to be generally well tolerated, with
somnolence as the only adverse event occurring at a rate of 5
percent or greater and twice placebo.
INGREZZA inhibits VMAT2 and 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 TD. VMAT2 is a protein in the brain that packages
neurotransmitters, such as dopamine, for transport and release in
presynaptic neurons. INGREZZA, developed in Neurocrine's
laboratories, 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 together with
psychiatric medications such as antipsychotics or
antidepressants.
Breakthrough Therapy Designation was received from the FDA for
INGREZZA for the treatment of TD, and the New Drug Application was
evaluated by the FDA with priority review.
Important Safety Information
INGREZZA can cause somnolence. Patients should not perform
activities requiring mental alertness such as operating a motor
vehicle or operating hazardous machinery until they know how they
will be affected by INGREZZA.
INGREZZA may prolong the QT interval, although the degree of QT
prolongation is not clinically significant at concentrations
expected with recommended dosing. INGREZZA should be avoided in
patients with congenital long QT syndrome or with arrhythmias
associated with a prolonged QT interval.
The most common adverse reaction (5% or greater and twice the
rate of placebo) is somnolence.
Please see INGREZZA full Prescribing Information at
www.INGREZZA.com.
About Neurocrine Biosciences
Neurocrine Biosciences is a San
Diego based biotechnology company focused on neurologic,
psychiatric and endocrine related disorders. The Company's three
late-stage clinical programs are: elagolix, a
gonadotropin-releasing hormone antagonist for women's health that
is partnered with AbbVie Inc.; opicapone, a novel, once-daily,
peripherally-acting, highly-selective catechol-o-methyltransferase
inhibitor under investigation as adjunct therapy to levodopa in
Parkinson's patients; and INGREZZA™ (valbenazine), a novel,
once-daily, selective VMAT2 inhibitor under investigation for the
treatment of Tourette Syndrome.
Neurocrine Biosciences, Inc. news releases are available through
the Company's website 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. These statements include, but are not limited to,
statements related to the benefits to be derived from Neurocrine's
products and product candidates, including INGREZZA; the size of
the U.S. market for INGREZZA; the value INGREZZA brings to
patients; the timing of INGREZZA's availability; the ability of
Neurocrine to ensure patients have access to INGREZZA; and whether
results from INGREZZA's clinical trials are indicative of
real-world results. 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 the commercialization of
INGREZZA or the development of the Company's product candidates;
whether INGREZZA receives adequate reimbursement from third-party
payors; the degree and pace of market uptake of INGREZZA; 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
clinical trials 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 that the Company will be unable to raise
additional funding, if required, to complete development of its
product candidates or to commercialize INGREZZA; the Company's
ability to meet any of its previously disclosed milestones or
financial projections, and changes to the assumptions underlying
such projected milestones or financial projections; 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, 2016. The Company
disclaims any obligation to update the statements contained in this
press release after the date hereof.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/neurocrine-announces-fda-approval-of-ingrezza-valbenazine-capsules-as-the-first-and-only-approved-treatment-for-adults-with-tardive-dyskinesia-td-with-multimedia-300438365.html
SOURCE Neurocrine Biosciences, Inc.