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Highlighted poster presentations on INGREZZA include data from two long-term studies examining the treatment's safety and efficacy over 48 weeks in patients with tardive dyskinesia, including patient-reported outcome results from the Phase III KINECT 4 study and an open-label, rollover trial reporting on symptom improvement and patient satisfaction with treatment.
Neurocrine will also present three analyses on opicapone from the Phase III BIPARK-I study highlighting the efficacy and safety of once-daily opicapone treatment in patients with Parkinson's disease, compared to placebo and entacapone. Primary outcomes from the BIPARK-I study were previously published in Lancet Neurology, with the outcomes from the open-label extension phase of the BIPARK-I study subsequently published in Neurology.
The five Neurocrine-sponsored abstracts that will be presented at the
Oral Presentation Session:
- Effects of Long-Term Valbenazine on Tardive Dyskinesia and Patient-Reported Outcomes: Results from the KINECT 4 Study
Abstract OP-02-11, Oral Poster Session II: Ataxias, Tics and/or Myoclonus, Dystonia, Gait and Other Movement Disorders, Tremors,Monday, Aug. 20 ,3:45-5:15 p.m. CEST
Poster Presentation Sessions:
- Global Improvement and Patient Satisfaction: Results from a Long-Term, Open-Label, Rollover Study of Valbenazine in Tardive Dyskinesia
Abstract P 206, Poster Exhibition: Gait and Other Movement Disorders,Monday, Aug. 20 ,12:15-1:15 p.m. CEST - Switch of Double-Blind Opicapone, Entacapone, or Placebo to Open-Label Opicapone: Efficacy Results of the 1-Year Extension of Study BIPARK I
Abstract P 208, Poster Exhibition: Gait and Other Movement Disorders,Monday, Aug. 20 ,12:15-1:15 p.m. CEST - Efficacy of Opicapone in Parkinson's Disease Patients with Motor Fluctuations: Results from the BIPARK I Study
Abstract P 207, Poster Exhibition: Gait and Other Movement Disorders,Tuesday, Aug. 21 ,12:15-1:15 p.m. CEST - Opicapone as Adjunctive Therapy to Levodopa in Patients with Parkinson's Disease and Motor Fluctuations: Global Impressions of Change Compared to Placebo and Entacapone
Abstract P 141, Poster Exhibition: Parkinson Disease,Tuesday, Aug. 21 ,12:15-1:15 p.m. CEST
About Tardive Dyskinesia (TD)
Tardive dyskinesia (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 commonly prescribed to treat mental illnesses such as schizophrenia, bipolar disorder and depression and certain anti-nausea medications. 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® (valbenazine) capsules
INGREZZA, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is the first FDA-approved product indicated for the treatment of adults with tardive dyskinesia, a condition associated with uncontrollable, abnormal and repetitive movements of the trunk, extremities and/or face.
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 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 for the treatment of tardive dyskinesia as one capsule, once-daily, together with psychiatric medications such as antipsychotics or antidepressants.
Important Safety Information
Warnings & Precautions
Somnolence
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.
QT Prolongation
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. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.
Adverse Reactions
The most common adverse reaction (≥5% and twice the rate of placebo) is somnolence. Other adverse reactions (≥2% and >placebo) include: anticholinergic effects, balance disorders/falls, headache, akathisia, vomiting, nausea, and arthralgia.
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-
Please see INGREZZA full Prescribing Information at www.INGREZZAHCP.com
About Parkinson's Disease
Parkinson's disease is a chronic and progressive movement disorder that affects approximately one million people in
About Opicapone
Opicapone, an investigational treatment for Parkinson's disease, is a novel, once-daily, peripherally-acting, selective catechol-o-methyltransferase (COMT) inhibitor proposed for use as adjunct therapy to levodopa/DOPA decarboxylase inhibitors in Parkinson's patients experiencing motor fluctuations. Opicapone works by prolonging the duration of effect of levodopa through decreasing its conversion rate into 3-O-methyldopa. A novel compound discovered in the BIAL – Portela & CA, S.A. (BIAL) laboratories, it is designed to provide patients and physicians with a once-daily option for the treatment of Parkinson's disease.
In
About 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 related to the benefits to be derived from Neurocrine's products and product candidates, including INGREZZA and opicapone; the value INGREZZA and/or our product candidates may bring to patients; the continued success of the launch of INGREZZA; the timing of completion of our clinical and other development activities and those of our collaboration partners. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: the Company's future financial and operating performance; risks and uncertainties associated with the commercialization of INGREZZA and ORILISSA, including the likelihood of continued revenue and prescription growth of INGREZZA; risks or uncertainties related to the development of the Company's product candidates; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA, ORILISSA, or a product candidate; risks associated with the Company's dependence on third parties for development and manufacturing activities related to INGREZZA and the Company's product candidates, and the ability of the Company to manage these third parties; risks that the
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SOURCE
Neurocrine Biosciences, Inc., Navjot Rai (Media & Investors), 858-617-7623, IR@neurocrine.com