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Neurocrine Biosciences Presents New Data Showing Significant Patient-Reported Improvements in Health-Related Quality of Life with INGREZZA® (valbenazine) Capsules in Older Adults with Tardive Dyskinesia

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Neurocrine Biosciences (NBIX) presented new Phase 4 data showing INGREZZA (valbenazine) significantly improved health-related quality of life in older adults with tardive dyskinesia. The post-hoc analyses, involving 29 patients aged 65+ years, demonstrated that continued INGREZZA treatment led to substantial improvements in functional status compared to placebo. The study used two validated assessment tools: the EQ-5D-5L for measuring health status across five dimensions and the Sheehan Disability Scale for functional impairment. These findings expand on previous studies, including KINECT 3 and KINECT 4, which showed long-term safety and efficacy in older adults. The results are particularly significant as older adults face increased risk of developing tardive dyskinesia and its associated physical, functional, and social impacts.
Neurocrine Biosciences (NBIX) ha presentato nuovi dati di Fase 4 che mostrano come INGREZZA (valbenazina) migliori significativamente la qualità della vita correlata alla salute negli anziani affetti da discinesia tardiva. Le analisi post-hoc, condotte su 29 pazienti di età superiore a 65 anni, hanno dimostrato che il trattamento continuativo con INGREZZA ha portato a miglioramenti sostanziali nello stato funzionale rispetto al placebo. Lo studio ha utilizzato due strumenti di valutazione validati: l'EQ-5D-5L per misurare lo stato di salute su cinque dimensioni e la Sheehan Disability Scale per la compromissione funzionale. Questi risultati ampliano quelli di studi precedenti, tra cui KINECT 3 e KINECT 4, che avevano evidenziato la sicurezza e l'efficacia a lungo termine negli anziani. I risultati sono particolarmente rilevanti poiché gli anziani sono maggiormente a rischio di sviluppare discinesia tardiva e le sue conseguenze fisiche, funzionali e sociali.
Neurocrine Biosciences (NBIX) presentó nuevos datos de Fase 4 que muestran que INGREZZA (valbenazina) mejora significativamente la calidad de vida relacionada con la salud en adultos mayores con discinesia tardía. Los análisis post-hoc, que involucraron a 29 pacientes de 65 años o más, demostraron que el tratamiento continuo con INGREZZA condujo a mejoras sustanciales en el estado funcional en comparación con el placebo. El estudio utilizó dos herramientas de evaluación validadas: el EQ-5D-5L para medir el estado de salud en cinco dimensiones y la Escala de Discapacidad de Sheehan para la discapacidad funcional. Estos hallazgos amplían estudios previos, incluidos KINECT 3 y KINECT 4, que mostraron seguridad y eficacia a largo plazo en adultos mayores. Los resultados son especialmente significativos ya que los adultos mayores enfrentan un mayor riesgo de desarrollar discinesia tardía y sus impactos físicos, funcionales y sociales asociados.
Neurocrine Biosciences(NBIX)는 INGREZZA(발베나진)가 지연성 운동장애를 가진 노인들의 건강 관련 삶의 질을 크게 향상시킨다는 새로운 4상 임상 데이터 결과를 발표했습니다. 65세 이상 29명의 환자를 대상으로 한 사후 분석에서 INGREZZA 지속 치료가 위약 대비 기능 상태를 크게 개선하는 것으로 나타났습니다. 연구에서는 건강 상태를 다섯 가지 차원에서 측정하는 EQ-5D-5L과 기능 장애를 평가하는 Sheehan 장애 척도라는 두 가지 검증된 평가 도구를 사용했습니다. 이 결과는 노인에서 장기적인 안전성과 효능을 보여준 이전 연구인 KINECT 3 및 KINECT 4의 결과를 확장한 것입니다. 특히 노인은 지연성 운동장애 및 그에 따른 신체적, 기능적, 사회적 영향에 대한 위험이 높아 이번 결과가 매우 중요합니다.
Neurocrine Biosciences (NBIX) a présenté de nouvelles données de phase 4 montrant qu'INGREZZA (valbénazine) améliore significativement la qualité de vie liée à la santé chez les personnes âgées atteintes de dyskinésie tardive. Les analyses post-hoc, portant sur 29 patients âgés de 65 ans et plus, ont démontré que le traitement continu par INGREZZA entraînait des améliorations substantielles du statut fonctionnel par rapport au placebo. L'étude a utilisé deux outils d'évaluation validés : l'EQ-5D-5L pour mesurer l'état de santé sur cinq dimensions et l'échelle de handicap de Sheehan pour l'évaluation de l'incapacité fonctionnelle. Ces résultats complètent les études antérieures, notamment KINECT 3 et KINECT 4, qui avaient démontré la sécurité et l'efficacité à long terme chez les personnes âgées. Ces résultats sont particulièrement importants car les personnes âgées présentent un risque accru de développer une dyskinésie tardive ainsi que ses impacts physiques, fonctionnels et sociaux associés.
Neurocrine Biosciences (NBIX) stellte neue Phase-4-Daten vor, die zeigen, dass INGREZZA (Valbenazin) die gesundheitsbezogene Lebensqualität bei älteren Erwachsenen mit tardiver Dyskinesie signifikant verbessert. Die Post-hoc-Analysen mit 29 Patienten ab 65 Jahren zeigten, dass die fortgesetzte Behandlung mit INGREZZA im Vergleich zu Placebo zu erheblichen Verbesserungen im funktionellen Status führte. Die Studie verwendete zwei validierte Bewertungsinstrumente: den EQ-5D-5L zur Messung des Gesundheitszustands in fünf Dimensionen und die Sheehan Disability Scale zur Beurteilung funktioneller Beeinträchtigungen. Diese Ergebnisse erweitern frühere Studien, darunter KINECT 3 und KINECT 4, die die Langzeitsicherheit und Wirksamkeit bei älteren Erwachsenen belegt haben. Die Resultate sind besonders bedeutsam, da ältere Erwachsene ein erhöhtes Risiko für die Entwicklung tardiver Dyskinesie sowie deren körperliche, funktionelle und soziale Auswirkungen haben.
Positive
  • Post-hoc analyses showed significant improvements in quality of life and functional status for older adults continuing INGREZZA treatment
  • Results support previous long-term safety and efficacy data from KINECT 3 and KINECT 4 studies in older adults
  • Study used clinically validated assessment tools (EQ-5D-5L and SDS) providing robust scientific measures
Negative
  • None.

Insights

INGREZZA data shows improved quality of life in elderly tardive dyskinesia patients, strengthening its clinical profile and market position.

Neurocrine's new Phase 4 post-hoc analyses demonstrate significant patient-reported improvements in health-related quality of life among adults aged 65+ with tardive dyskinesia who continued INGREZZA treatment versus those switched to placebo. This data is particularly meaningful as older adults represent a high-risk population for tardive dyskinesia with greater susceptibility to its functional consequences.

The study utilized two clinically validated assessment tools - the EQ-5D-5L and Sheehan Disability Scale - providing robust scientific evidence of INGREZZA's benefits beyond simply reducing movement symptoms. This builds upon Neurocrine's earlier KINECT-PRO study, which was the first to demonstrate patient-reported improvements with a VMAT2 inhibitor.

What makes this data strategically valuable is how it differentiates INGREZZA in the competitive VMAT2 inhibitor market. By demonstrating benefits in patient-reported outcomes specifically in elderly populations, Neurocrine strengthens INGREZZA's position against competitors like Teva's Austedo and Mitsubishi Tanabe's DYSPORT. The focus on quality of life measurements aligns with healthcare's shift toward patient-centered outcomes and value-based care models.

The timing is also notable - by presenting at the AANP National Conference, Neurocrine targets nurse practitioners who play an increasingly important role in psychiatric medication management, potentially expanding INGREZZA's prescriber base beyond psychiatrists and neurologists.

  • Data Add to Growing Body of Evidence Demonstrating Functional and Quality of Life Improvements in Patients Treated with INGREZZA for Tardive Dyskinesia
     
  • Findings Presented at the 2025 American Association of Nurse Practitioners (AANP) National Conference 

SAN DIEGO, June 20, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the presentation of new analyses from a Phase 4 randomized withdrawal study demonstrating significant patient-reported improvements in health-related quality of life and functional measures among adults aged 65 years and older with tardive dyskinesia who received continued treatment with INGREZZA® (valbenazine) capsules. Findings will be presented at the 2025 American Association of Nurse Practitioners National Conference in San Diego. These post-hoc analyses of older adults expand on recently announced Phase 4 study results, which demonstrated that continued treatment with INGREZZA improved functional status and quality of life measures across the general patient population.

"Older adults are not only at increased risk for developing tardive dyskinesia, but are also more susceptible to the profound physical, functional and social consequences of their uncontrolled movements," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "These new post-hoc analyses demonstrate that INGREZZA can provide significant and persistent improvements in quality of life for older adults with tardive dyskinesia and are consistent with the unique and substantial body of evidence that INGREZZA treatment can provide robust improvement in outcomes beyond tardive dyskinesia severity."

The analyses were conducted in a subset of 29 adult patients (≥65 years) who participated in a Phase 4, double-blind, placebo-controlled, randomized withdrawal study (NCT03891862). During an initial eight-week, open-label period, all patients received up to 80 mg of INGREZZA daily. At Week 8 (randomization baseline), patients were randomized to either continue INGREZZA (n=13) or switch to placebo (n=16) for an additional eight weeks. Analyses were conducted for patients who had available data during the double-blind period from Week 8 to Week 16.

Patients who received continued treatment with INGREZZA reported significant improvements in health-related quality of life and functional status, compared with those randomized to placebo. Two clinically validated scales were used to assess patient-reported outcomes, providing a comprehensive and scientifically robust measure of health status:

  • The EuroQol 5-Dimension 5-Level (EQ-5D-5L) assessment tool, which measures health-related quality of life across five dimensions of health status (mobility, self-care, usual activities, pain/discomfort and anxiety/depression).
  • The Sheehan Disability Scale (SDS), which measures patient-reported functional impairment in work/school, social life and family/home life impairment.

These analyses contribute to the growing body of evidence for INGREZZA use in older adults (>65 years). A recently published post-hoc analysis from two 48-week studies, the KINECT® 3 extension and KINECT® 4, demonstrated the long-term safety profile and robust efficacy of INGREZZA in adults aged 65 years and older with tardive dyskinesia (TD). In addition, the analyses further reinforce findings from the KINECT-PRO™ study of INGREZZA – a first-of-its-kind study that demonstrated clinically meaningful improvement in patient-reported impact of TD with a vesicular monoamine transporter 2 inhibitor and used multiple clinically validated, patient-reported scales.

Additional presentations at the 2025 AANP National Conference include:

  • Real-World Insights on Tardive Dyskinesia: A Claims-Based Analysis of Demographics and Healthcare Resource Utilization (Poster #24)

  • Clinically Meaningful Long-Term Improvements with Valbenazine 40 mg in Adults with Tardive Dyskinesia (Poster #25)

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 the KINECT-PRO™ Phase 4 Study
The KINECT-PRO™ Phase 4, open-label study was designed to evaluate patient-reported outcomes on the use of INGREZZA® (valbenazine) capsules in a tardive dyskinesia (TD) patient population reflective of real-world clinical practice. Participants had at least mild TD, were aware of and experiencing at least mild distress from their abnormal, involuntary movements and had a clinical diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or major depression. The KINECT-PRO study included a four-week screening period, a 24-week treatment period during which participants received 40 mg of INGREZZA once-daily for the first four weeks, followed by flexible dosing of 40 mg, 60 mg or 80 mg once-daily based on individual treatment needs and a two-week safety follow-up period. Baseline socio-demographic and clinical characteristics of the participants were broadly similar to those of the KINECT® 3 and KINECT® 4 studies.

KINECT-PRO is the first and only study to specifically evaluate and demonstrate patient-reported improvement with vesicular monoamine transporter 2 inhibitor treatment on TD using multiple clinically validated scales, including the Tardive Dyskinesia Impact Scale (TDIS™). The TDIS is the only patient-reported outcome instrument designed for and validated in tardive dyskinesia patients that measures the physical, social and emotional impact of the involuntary movements of the condition. 

About the Tardive Dyskinesia Impact Scale
The Tardive Dyskinesia Impact Scale (TDIS) is a novel, psychometrically validated patient-reported outcome measure in TD. It was developed by Neurocrine Biosciences from qualitative studies and Phase 3 trials of INGREZZA for the treatment of TD (KINECT 3 and KINECT 4) as a comprehensive measure of impact and burden of TD from a patient's perspective. The TDIS consists of 11 questions evaluating physical and socio-emotional impact. Six domains are assessed: mouth/throat, dexterity, mobility, pain, social and emotional. The TDIS allows people with TD to rate how their symptoms affect daily activities and how their uncontrollable movements make them feel. The questionnaire captures relevant information about the impact of TD to provide a more holistic assessment of the condition. Validation of this scale was published in the Journal of Patient-Reported Outcomes

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 studied 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 dyskinesiaare 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, INGREZZA and KINECT are registered trademarks of Neurocrine Biosciences, Inc. KINECT-PRO and TDIS are trademarks 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-0069 06/2025

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SOURCE Neurocrine Biosciences, Inc.

FAQ

What were the key findings of NBIX's Phase 4 INGREZZA study in older adults?

The study showed significant improvements in health-related quality of life and functional measures among adults aged 65+ with tardive dyskinesia who received continued INGREZZA treatment compared to placebo.

How many patients were included in NBIX's INGREZZA study for older adults?

The post-hoc analyses included 29 adult patients aged 65 years and older, with 13 continuing INGREZZA treatment and 16 switching to placebo.

What assessment tools were used in the NBIX INGREZZA Phase 4 study?

The study used two validated tools: the EQ-5D-5L for measuring health status across five dimensions and the Sheehan Disability Scale for functional impairment assessment.

Why is INGREZZA's effectiveness in older adults particularly important?

Older adults are at increased risk for developing tardive dyskinesia and are more susceptible to its physical, functional, and social consequences, making effective treatment crucial for this population.

What previous studies support INGREZZA's use in older adults with tardive dyskinesia?

The KINECT 3 extension and KINECT 4 studies, both 48-week studies, demonstrated long-term safety and robust efficacy of INGREZZA in adults aged 65+ with tardive dyskinesia.
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