TD is an involuntary movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts that can be disruptive and negatively impact patients. The abnormal and involuntary movements of TD can impact patients socially, emotionally and physically, causing patients to feel embarrassed or judged by others or withdraw from society and isolate themselves.
"The RE-KINECT study provides valuable insights into the real-world and personal impact the involuntary movements from possible tardive dyskinesia may have on the everyday life of a patient. Through objective, standardized and systematic measurements, this study helped document the negative effect of abnormal movements on multiple aspects of functioning and quality of life in patients with possible tardive dyskinesia," said
RE-KINECT was designed to better understand the significance of possible TD and its impact on patients treated with antipsychotic medications, including the effect on quality of life as reported by patients and caregivers. Data from RE-KINECT demonstrated that patients with clinician-confirmed possible TD (n=204) reported a higher percentage of moderate (score=3), severe (score=4) or extreme (score=5) problems in the following areas of the EuroQoL 5-Dimension 5-Level (EQ‑5D-5L) questionnaire compared to patients without clinician-confirmed possible TD (n=450):
- Nearly 30% (28.7%) of patients with possible TD (n=202) reported moderate-to-extreme problems performing their usual activities, including work, housework and leisure activities, compared to 19.5% of patients without possible TD (n=447).
- Almost half of patients (47.5%) with possible TD (n=202) reported they experienced moderate-to-extreme levels of anxiety/depression, compared to 39.5% of patients without possible TD (n=446).
- 20.9% of patients with possible TD (n=201) reported moderate-to-extreme mobility problems, compared to 12.1% of patients without possible TD (n=446).
- In a regression model, EQ-5D-5L utility scores showed poorer perceived quality of life in patients with possible TD who reported "a lot" of severity (n=53) or "a lot" of impact (n=33) on daily activities, compared to patients without possible TD.1
"Results from RE-KINECT clearly demonstrate the burden involuntary movements have on patients, including an impact on family, work and social life. In patients who rated their possible tardive dyskinesia symptoms as having "a lot" of severity or "a lot" of impact on daily activities, the negative effect on their quality of life was especially apparent," said Eiry W. Roberts, M.D., Chief Medical Officer at
About the RE-KINECT Study
RE-KINECT is a prospective real-world screening study that included 739 patients from 37 outpatient psychiatry practices in the U.S. The study objective was to assess the presence and impact of possible tardive dyskinesia (TD) and describe the associated disease burden in a cohort of patients with one or more psychiatric disorders and a cumulative lifetime exposure to antipsychotic medication of three months or more. Patients were clinically evaluated for abnormal involuntary movements in general body regions (head/face, neck/trunk, upper/lower limbs) as well as for possible TD. Demographics, psychiatric history and medication history were captured as part of a 12-month retrospective chart review. Health-related quality of life was evaluated using the EuroQoL 5 Dimensions (EQ-5D-5L) questionnaire, which includes five domains that are each scored on a scale of 1 ("no problems") to 5 ("unable to perform") and the Sheehan Disability Scale (SDS), which is a brief patient-rated measure for disability and impairment, that includes three domains that are scored on a scale of 0 "not at all" to 10 "extremely."
About the KINECT 4 Phase III Study
KINECT 4 is a Phase III, 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.
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 caused by prolonged use of 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
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
Contraindications
INGREZZA is contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported.
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.INGREZZA.com/PI.
About
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 INGREZZA and the continued success of the launch of INGREZZA. 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 and uncertainties relating to factors 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 the
1 The severity of possible TD in each of 4 body regions was rated by both patients and clinicians as follows: 0=none, 1=some, and 2=a lot. Patients also rated the impact of possible TD in each of 7 daily activity domains using the same item responses.
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Neurocrine Biosciences, Navjot Rai (Media & Investors), 858-617-7623, IR@neurocrine.com