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SAN DIEGO , May 16, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX ) today announced the presentation of new analyses from a Phase 4 randomized withdrawal study (NCT03891862) showing patients with tardive dyskinesia who received continued treatment with INGREZZA ® (valbenazine) capsules reported improvements across functional and health-related quality of life measures. These findings complement recently announced patient-reported outcome data from the Phase 4 KINECT-PRO™ study of INGREZZA, which was the first of its kind to specifically measure and report clinically meaningful improvements in the impact of tardive dyskinesia. The analyses were presented at the 2025 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Conference in Montreal, Canada .
"Tardive dyskinesia can affect patients' daily lives, causing pain and anxiety and hindering the ability to perform self-care tasks and to participate in work, family or social life," said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences. "These unique analyses add to the expansive body of evidence demonstrating that INGREZZA treatment can significantly improve tardive dyskinesia patients' quality of life, addressing outcomes important to both patients and healthcare providers."
The analyses were conducted using data from 127 patients who participated in a Phase 4, double-blind, placebo-controlled, randomized withdrawal study. Patients received up to 80 mg of INGREZZA for eight weeks, after which they were randomized to either continue INGREZZA (n=59) or receive placebo (n=59) for an additional eight weeks.
In the open-label portion of the study, patients receiving INGREZZA treatment for eight weeks experienced significant improvements from baseline in multiple areas of HRQoL (Poster #PCR191), including mobility (change from baseline: -0.27), self-care (-0.28), usual activities (-0.36) and pain/discomfort (-0.34). Those randomized to receive INGREZZA for an additional eight weeks (Week 16) saw continued improvements in all HRQoL dimensions, including significant improvements in mobility (placebo-adjusted difference from Week 8: -0.34) and anxiety/depression (-0.38) compared with those receiving placebo.
In a separate analysis (Poster #PCR190), patients in the open-label portion of the same study receiving INGREZZA treatment for eight weeks experienced significant improvements from baseline in work/school (change from baseline: -1.37), social life (-1.65), family/home life (-1.30) and SDS total score (-4.28). Those randomized to receive INGREZZA for an additional eight weeks saw continued improvements in all domains, including significant improvements in social life (placebo-adjusted difference from Week 8: -0.95) and family/home life (-0.89) compared with those receiving placebo.
Additional presentations at the 2025 ISPOR annual meeting include:
About Tardive Dyskinesia Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrolled, 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 (antipsychotics) that help control dopamine receptors in the brain. Taking antipsychotics commonly prescribed to treat mental illnesses such as major depressive disorder, bipolar disorder, schizophrenia and schizoaffective disorder and other prescription medicines (metoclopramide and prochlorperazine) used to treat gastrointestinal disorders 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 mild to severe and are often persistent and irreversible. TD is estimated to affect at least 800,000 adults in the U.S.
About Chorea Associated with Huntington's Disease Huntington's disease (HD) is a hereditary progressive neurodegenerative disorder in which the loss of certain neurons within the brain causes motor, cognitive and psychiatric symptoms. Symptoms generally appear between the ages of 30 and 50 years and worsen over a 10- to 25-year period. Most people with HD experience chorea, an abnormal involuntary movement disorder, characterized by irregular and unpredictable movements. Chorea can affect various body parts and interfere with motor coordination, gait, swallowing and speech. HD is estimated to affect approximately 41,000 adults in the U.S., with more than 200,000 at risk of inheriting the disease.
About INGREZZA ® (valbenazine) Capsules and INGREZZA ® SPRINKLE (valbenazine) Capsules INGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease (HD). Only INGREZZA offers a therapeutic dose from day one with no required titration.
INGREZZA, developed by Neurocrine Biosciences, selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. While the specific way INGREZZA works to treat TD and HD chorea is not fully understood, INGREZZA is unique in that it selectively and specifically targets VMAT2 to inhibit the release of dopamine, a chemical in the brain that helps control movement. INGREZZA is believed to reduce extra dopamine signaling, which may lead to fewer uncontrollable movements.
INGREZZA is proven across the widest range of patients. It is always one capsule, once daily and can be taken together with most stable mental health regimens such as antipsychotics or antidepressants. Only INGREZZA offers the benefit of a sprinkle formulation, INGREZZA SPRINKLE, for those who experience dysphagia, have difficulty swallowing or prefer not to swallow a pill. INGREZZA and INGREZZA SPRINKLE dosages approved for use are 40 mg, 60 mg and 80 mg capsules.
Important Information Approved Uses INGREZZA ® (valbenazine) capsules or INGREZZA ® SPRINKLE (valbenazine) capsules are prescription medicines used to treat adults with:
It is not known if INGREZZA or INGREZZA SPRINKLE is safe and effective in children.
IMPORTANT SAFETY INFORMATION
INGREZZA or INGREZZA SPRINKLE can cause serious side effects in people with Huntington's disease, including: depression, suicidal thoughts, or suicidal actions. Tell your healthcare provider before you start taking INGREZZA or INGREZZA SPRINKLE if you have Huntington's disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA or INGREZZA SPRINKLE is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself.
Do not take INGREZZA or INGREZZA SPRINKLE if you:
INGREZZA or INGREZZA SPRINKLE can cause serious side effects, including:
Before taking INGREZZA or INGREZZA SPRINKLE, 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. Make sure you tell all of your healthcare providers that you are taking INGREZZA or INGREZZA SPRINKLE. Taking INGREZZA or INGREZZA SPRINKLE with certain other medicines may cause serious side effects. Especially tell your healthcare provider if you: take digoxin or take or have taken a monoamine oxidase inhibitor (MAOI) medicine. You should not take INGREZZA or INGREZZA SPRINKLE if you are taking, or have stopped taking, a MAOI within the last 14 days.
The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with tardive dyskinesia are sleepiness and tiredness.
The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with chorea associated with Huntington's disease include sleepiness and tiredness, raised itchy red areas on your skin (hives), rash, and trouble getting to sleep or staying asleep.
These are not all of the possible side effects of INGREZZA or INGREZZA SPRINKLE. 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.
Dosage Forms and Strengths: INGREZZA and INGREZZA SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules.
Please see full Prescribing Information , including Boxed Warning, and Medication Guide .
About Neurocrine Biosciences, Inc. Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. 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, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core 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 , X and Facebook . ( *in collaboration with AbbVie )
The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE and INGREZZA are registered trademarks of Neurocrine Biosciences, Inc. KINECT-PRO is a trademark of Neurocrine Biosciences, Inc.
SOURCE Neurocrine Biosciences, Inc.