Full Press Release Details
SAN DIEGO , March 3, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX ) today announced it will present data analyzing the long-term outcomes of treating tardive dyskinesia (TD) with INGREZZA ® (valbenazine) capsules in older (≥55 years) and elderly (≥65 years) patients from two studies (KINECT ™ 3-extension and KINECT ™ 4). These data (Poster #NR-36, Improvements Over Time with Long-Term Valbenazine in Older and Elderly Patients with Tardive Dyskinesia) are being presented at the American Association for Geriatric Psychiatry (AAGP) 2023 Annual Meeting from March 3–6 in New Orleans .
The data demonstrated that long-term treatment with once-daily INGREZZA led to clinically meaningful reductions of TD symptoms in both older patients with TD and elderly patients. At 48 weeks of INGREZZA treatment, >80 percent of participants in the ≥65 years age group met the > 50 percent improvement in the Abnormal Involuntary Movement Scale (AIMS) response threshold. Analyses included the following:
Similar results were found in the ≥55 years age group. Mean changes from baseline to week 48 in psychiatric symptom scale scores were minimal, indicating maintenance of psychiatric stability in both age groups.
The Diagnostic Statistical Manual of Mental Disorders (DSM-5-TR) notes that middle-aged and elderly individuals have an increased risk for TD.
Key findings from the data analyses include:
Additional presentation includes:
The full abstracts being presented by Neurocrine Biosciences at AAGP 2023 are available on the meeting website and can be accessed by registering .
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 depression, bipolar disorder, schizophrenia and schizoaffective disorder, and certain medications to treat upset stomach, nausea, and vomiting 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
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:
INGREZZA may cause serious side effects, including :
Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you faint.
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 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 over a dozen mid- to late-stage clinical programs in multiple 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.
SOURCE Neurocrine Biosciences, Inc.