Neurocrine Biosciences Presents Data Adding to the Growing Body of Evidence Demonstrating Functional and Quality of Life Improvements in Patients with Tardive Dyskinesia
I pazienti trattati con INGREZZA hanno mostrato miglioramenti significativi in vari parametri della qualità della vita correlata alla salute, inclusi mobilità (-0,27), cura di sé (-0,28), attività abituali (-0,36) e dolore/disagio (-0,34). Coloro che hanno proseguito con INGREZZA per altre 8 settimane hanno evidenziato ulteriori miglioramenti, in particolare nella mobilità (-0,34) e nell’ansia/depressione (-0,38) rispetto al placebo.
Lo studio ha inoltre evidenziato miglioramenti funzionali significativi nel lavoro/scuola (-1,37), vita sociale (-1,65), vita familiare/domestica (-1,30) e nel punteggio totale SDS (-4,28). Il trattamento continuato ha mostrato benefici aggiuntivi nella vita sociale (-0,95) e familiare/domestica (-0,89) rispetto al placebo.
Los pacientes que recibieron INGREZZA mostraron mejoras significativas en medidas de calidad de vida relacionada con la salud, incluyendo movilidad (-0,27), cuidado personal (-0,28), actividades habituales (-0,36) y dolor/molestias (-0,34). Aquellos que continuaron con INGREZZA por 8 semanas adicionales demostraron mejoras adicionales, especialmente en movilidad (-0,34) y ansiedad/depresión (-0,38) en comparación con el placebo.
El estudio también reveló mejoras funcionales significativas en trabajo/escuela (-1,37), vida social (-1,65), vida familiar/hogar (-1,30) y en la puntuación total SDS (-4,28). El tratamiento continuado mostró beneficios adicionales en vida social (-0,95) y vida familiar/hogar (-0,89) frente al placebo.
INGREZZA를 투여받은 환자들은 이동성(-0.27), 자기관리(-0.28), 일상활동(-0.36), 통증/불편감(-0.34) 등 건강 관련 삶의 질 지표에서 유의미한 개선을 보였습니다. 추가 8주간 INGREZZA를 계속 복용한 환자들은 위약군에 비해 특히 이동성(-0.34)과 불안/우울(-0.38)에서 더 큰 개선을 나타냈습니다.
또한 연구 결과는 직장/학교(-1.37), 사회생활(-1.65), 가족/가정생활(-1.30), SDS 총점(-4.28)에서 기능적 개선도 유의하게 나타났으며, 지속 치료군은 위약군 대비 사회생활(-0.95)과 가족/가정생활(-0.89)에서 추가적인 이점을 보였습니다.
Les patients sous INGREZZA ont montré des améliorations significatives des mesures de la qualité de vie liée à la santé, notamment la mobilité (-0,27), les soins personnels (-0,28), les activités habituelles (-0,36) et la douleur/gêne (-0,34). Ceux poursuivant INGREZZA pendant 8 semaines supplémentaires ont démontré des améliorations supplémentaires, particulièrement en mobilité (-0,34) et anxiété/dépression (-0,38) par rapport au placebo.
L'étude a également révélé des améliorations fonctionnelles significatives au travail/école (-1,37), vie sociale (-1,65), vie familiale/domicile (-1,30) et score total SDS (-4,28). Le traitement prolongé a montré des bénéfices supplémentaires dans la vie sociale (-0,95) et la vie familiale/domicile (-0,89) par rapport au placebo.
Patienten, die INGREZZA erhielten, zeigten signifikante Verbesserungen in gesundheitsbezogenen Lebensqualitätsmaßen, darunter Mobilität (-0,27), Selbstversorgung (-0,28), übliche Aktivitäten (-0,36) und Schmerz/Beschwerden (-0,34). Die Patienten, die INGREZZA weitere 8 Wochen fortsetzten, zeigten im Vergleich zum Placebo zusätzliche Verbesserungen, insbesondere bei Mobilität (-0,34) und Angst/Depression (-0,38).
Die Studie zeigte außerdem signifikante funktionelle Verbesserungen bei Arbeit/Schule (-1,37), Sozialleben (-1,65), Familien-/Heimleben (-1,30) und im SDS-Gesamtwert (-4,28). Die fortgesetzte Behandlung brachte zusätzliche Vorteile im Sozialleben (-0,95) und Familien-/Heimleben (-0,89) gegenüber Placebo.
- Significant improvements demonstrated across multiple quality of life measures including mobility, self-care, and usual activities
- Continued treatment showed sustained benefits compared to placebo in functional measures
- Notable improvements in work, social life, and family life metrics
- Study validates INGREZZA's effectiveness in addressing both symptoms and quality of life aspects
- None.
Insights
INGREZZA treatment shows functional improvements in tardive dyskinesia patients, strengthening NBIX's position with meaningful quality of life data.
Neurocrine Biosciences has presented compelling new evidence that strengthens the clinical profile of INGREZZA (valbenazine) in treating tardive dyskinesia. The Phase 4 randomized withdrawal study data specifically demonstrates improvements in functional and health-related quality of life measures, which are critical factors beyond symptom control.
The study design is particularly robust - patients received 8 weeks of INGREZZA treatment followed by randomization to either continue treatment or switch to placebo for 8 additional weeks. This withdrawal methodology provides strong evidence of continued drug benefit by comparing maintained treatment versus discontinuation.
The data shows significant improvements in multiple domains during the initial 8-week treatment period, including mobility (-0.27), self-care (-0.28), usual activities (-0.36), and pain/discomfort (-0.34). Importantly, patients continuing INGREZZA for the additional 8 weeks demonstrated further improvements in mobility and anxiety/depression compared to those switched to placebo.
The functional improvement data is particularly notable - patients showed significant improvements in work/school functioning (-1.37), social life (-1.65), family/home life (-1.30), and overall disability score (-4.28). Those continuing INGREZZA treatment saw continued improvement in social and family life compared to placebo.
These findings are valuable because tardive dyskinesia isn't merely a movement disorder - it significantly impairs patients' functionality and quality of life. By demonstrating improvements in these patient-centered outcomes, INGREZZA is showing benefits that matter to patients beyond the clinical rating scales typically used in movement disorders. This data complements their KINECT-PRO study results, building a comprehensive clinical profile that should strengthen INGREZZA's position in treatment guidelines and clinical practice.
New quality-of-life data strengthens INGREZZA's market position by addressing key patient concerns beyond symptom control.
This new patient-reported outcomes data represents a strategic expansion of INGREZZA's clinical value proposition in the tardive dyskinesia market. By demonstrating improvements in functional capacity and quality of life, Neurocrine is addressing what truly matters to patients and providers beyond mere symptom reduction.
The data highlights improvements across five critical dimensions of health status (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and functional domains (work/school, social life, family/home life). These patient-centric outcomes directly address the disability burden of tardive dyskinesia.
From a market positioning perspective, this quality-of-life data serves multiple strategic purposes. First, it differentiates INGREZZA from competitors by focusing on holistic patient outcomes. Second, it provides compelling evidence for payers who increasingly demand demonstrations of functional improvement, not just symptom control. Third, it gives prescribers patient-relevant talking points when discussing treatment options.
The timing of this data is also notable - Neurocrine is presenting multiple analyses at ISPOR, a conference specifically focused on health economics and outcomes research, signaling a coordinated effort to build their health economics and outcomes research (HEOR) profile. Their concurrent presentations examining real-world dosing patterns, treatment disparities, and comparative efficacy suggest a comprehensive strategy to maintain INGREZZA's market leadership.
This quality-of-life data strengthens INGREZZA's value proposition at a time when payers and providers are increasingly focused on outcomes that matter to patients. By demonstrating benefits in daily functioning and quality of life, Neurocrine is addressing the full burden of tardive dyskinesia while potentially expanding their prescriber base beyond movement disorder specialists to psychiatrists who may be more focused on their patients' overall functioning.
- Patients Treated with INGREZZA® (valbenazine) Capsules Reported Continued Improvements in Functional and Health-Related Quality of Life Measures
- Findings Presented at 2025 International Society for Pharmacoeconomics and Outcomes Research Conference
"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.
- Health-related quality of life (HRQoL) was measured using the EuroQol 5-Dimension 5-Level (EQ-5D-5L), which includes five dimensions of health status (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). A utility index, ranging from -0.573 to 1.0, and visual analog scale (EQ-VAS), ranging from 0 to 100, were also reported with higher scores indicating better health status.
- Functional impairment was measured using the five-item Sheehan Disability Scale (SDS), in which three items assessed work/school (patient had to be working or attending school to be included), social life and family/home life impairment. Scores were combined for an SDS total score for patients with work/school scores. Reductions in scores indicated improvement.
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:
- Assessing Real-World Dosing Patterns for Vesicular Monoamine Transporter-2 Inhibitors, Valbenazine and Deutetrabenazine, Among Patients with Tardive Dyskinesia in a Nationwide US Claims Database (Poster #HSD80)
- Disparities in Tardive Dyskinesia Diagnosis and Treatment Among the US Medicare Population (Poster #HSD59)
- Disparities in Antipsychotic Prescribing Among the US Medicare Population (Podium Presentation)
- The Impact of Glucocorticoid Dose on Clinical Outcomes in Congenital Adrenal Hyperplasia: a Systematic Literature Review (Poster #CO16)
- Indirect Treatment Comparison for Early Efficacy of VMAT2 Inhibitors for Tardive Dyskinesia and Chorea Associated with Huntington's Disease (Poster #CO113)
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
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
About INGREZZA® (valbenazine) Capsules and INGREZZA® SPRINKLE (valbenazine) Capsules
INGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the
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:
- movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).
- involuntary movements (chorea) of Huntington's disease. INGREZZA or INGREZZA SPRINKLE do not cure the cause of involuntary movements, and do not treat other symptoms of Huntington's disease, such as problems with thinking or emotions.
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:
- are allergic to valbenazine, or any of the ingredients in INGREZZA or INGREZZA SPRINKLE.
INGREZZA or INGREZZA SPRINKLE can cause serious side effects, including:
- Allergic reactions. Allergic reactions, including an allergic reaction that causes sudden swelling called angioedema, can happen after taking the first dose or after many doses of INGREZZA or INGREZZA SPRINKLE. Signs and symptoms of allergic reactions and angioedema include: trouble breathing or shortness of breath, swelling of your face, lips, eyelids, tongue, or throat, or other areas of your skin, trouble with swallowing, or rash, including raised, itchy red areas on your skin (hives). Swelling in the throat can be life-threatening and can lead to death. Stop taking INGREZZA or INGREZZA SPRINKLE and go to the nearest emergency room right away if you develop these signs and symptoms of allergic reactions and angioedema.
- Sleepiness and tiredness that could cause slow reaction times (somnolence and sedation). Do not drive a car or operate dangerous machinery until you know how INGREZZA or INGREZZA SPRINKLE affects you. Drinking alcohol and taking other medicines may also cause sleepiness during treatment with INGREZZA or INGREZZA SPRINKLE.
- Heart rhythm problems (QT prolongation). INGREZZA or INGREZZA SPRINKLE may cause a heart rhythm problem known as QT prolongation. You have a higher chance of getting QT prolongation if you also take certain other medicines during treatment with INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider right away if you develop any signs or symptoms of QT prolongation, including: fast, slow, or irregular heartbeat (heart palpitations), shortness of breath, dizziness or lightheadedness, or fainting or feeling like you are going to faint.
- Neuroleptic Malignant Syndrome (NMS). NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to the nearest emergency room if you develop these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, irregular pulse or blood pressure, increased sweating, or very fast or uneven heartbeat.
- Parkinson-like symptoms. Symptoms include: body stiffness, drooling, trouble moving or walking, trouble keeping your balance, shaking (tremors), or falls.
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.
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 regarding the potential benefits to be derived from INGREZZA and the value INGREZZA may bring to patients. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of INGREZZA; whether INGREZZA receives adequate reimbursement from third-party payors; 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 may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended March 31, 2025. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law.
© 2025 Neurocrine Biosciences, Inc. All Rights Reserved. CAP-VBZ-US-0064 05/2025
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FAQ
What improvements did INGREZZA show in the Phase 4 study for tardive dyskinesia patients?
How many patients participated in Neurocrine's INGREZZA Phase 4 study?
What functional improvements were reported in the NBIX INGREZZA study?
How was quality of life measured in the INGREZZA Phase 4 study?
