Neurocrine Biosciences Presents 48-Week Remission Data on Treatment of Tardive Dyskinesia With INGREZZA® (valbenazine) Capsules
Neurocrine Biosciences (NBIX) has presented new long-term data from the KINECT® 4 study showing significant remission rates in tardive dyskinesia patients treated with INGREZZA® (valbenazine). The 48-week study involved 103 participants and demonstrated that 59.2% achieved remission, with consistent results across different doses and psychiatric conditions.
The study showed remarkable AIMS score improvements, with patients on 40 mg doses seeing scores decrease from 12.4 to 2.1, and those on 80 mg doses improving from 15.1 to 2.5. Specifically, 58.6% of participants on the 40 mg dose and 59.5% on the 80 mg dose achieved remission. The treatment proved effective across different psychiatric diagnoses, with 57.7% of schizophrenia/schizoaffective disorder patients and 62.5% of mood disorder patients reaching remission thresholds.
Neurocrine Biosciences (NBIX) ha presentato nuovi dati a lungo termine dallo studio KINECT® 4 che mostrano tassi di remissione significativi nei pazienti con discinesia tardiva trattati con INGREZZA® (valbenazina). Lo studio di 48 settimane ha coinvolto 103 partecipanti e ha dimostrato che il 59,2% ha raggiunto la remissione, con risultati coerenti tra diverse dosi e condizioni psichiatriche.
Lo studio ha mostrato miglioramenti notevoli nei punteggi AIMS, con i pazienti a dosi di 40 mg che hanno visto i punteggi diminuire da 12,4 a 2,1, e quelli a dosi di 80 mg che sono migliorati da 15,1 a 2,5. In particolare, il 58,6% dei partecipanti a 40 mg e il 59,5% a 80 mg hanno raggiunto la remissione. Il trattamento si è dimostrato efficace in diverse diagnosi psichiatriche, con il 57,7% dei pazienti con schizofrenia/disturbo schizoaffettivo e il 62,5% dei pazienti con disturbi dell'umore che hanno raggiunto le soglie di remissione.
Neurocrine Biosciences (NBIX) ha presentado nuevos datos a largo plazo del estudio KINECT® 4 que muestran tasas de remisión significativas en pacientes con discinesia tardía tratados con INGREZZA® (valbenazina). El estudio de 48 semanas involucró a 103 participantes y demostró que el 59.2% alcanzó la remisión, con resultados consistentes en diferentes dosis y condiciones psiquiátricas.
El estudio mostró mejoras notables en la puntuación AIMS, con pacientes en dosis de 40 mg viendo sus puntuaciones disminuir de 12.4 a 2.1, y aquellos en dosis de 80 mg mejorando de 15.1 a 2.5. Específicamente, el 58.6% de los participantes en la dosis de 40 mg y el 59.5% en la dosis de 80 mg alcanzaron la remisión. El tratamiento demostró ser efectivo en diferentes diagnósticos psiquiátricos, con el 57.7% de los pacientes con esquizofrenia/trastorno esquizoafectivo y el 62.5% de los pacientes con trastornos del estado de ánimo alcanzando los umbrales de remisión.
Neurocrine Biosciences (NBIX)는 INGREZZA®(발베나진)로 치료받은 지연성 운동장애 환자들에서 상당한 관해율을 보여주는 KINECT® 4 연구의 새로운 장기 데이터를 발표했습니다. 48주 연구에는 103명의 참가자가 포함되었으며, 59.2%가 관해에 도달했으며, 다양한 용량과 정신과적 상태에서 일관된 결과를 보여주었습니다.
연구에서는 AIMS 점수의 현저한 개선이 나타났으며, 40 mg 용량의 환자는 점수가 12.4에서 2.1로 감소했고, 80 mg 용량의 환자는 15.1에서 2.5로 개선되었습니다. 특히, 58.6%의 40 mg 용량 참가자와 59.5%의 80 mg 용량 참가자가 관해에 도달했습니다. 치료는 다양한 정신과적 진단에서 효과적이었으며, 57.7%의 조현병/조현 정서 장애 환자와 62.5%의 기분 장애 환자가 관해 기준에 도달했습니다.
Neurocrine Biosciences (NBIX) a présenté de nouvelles données à long terme de l'étude KINECT® 4 montrant des taux de rémission significatifs chez les patients atteints de dyskinésie tardive traités avec INGREZZA® (valbénazine). L'étude de 48 semaines a impliqué 103 participants et a démontré que 59,2% avait atteint la rémission, avec des résultats cohérents à travers différentes doses et conditions psychiatriques.
L'étude a montré des améliorations remarquables des scores AIMS, avec des patients sous 40 mg voyant leurs scores diminuer de 12,4 à 2,1, et ceux sous 80 mg améliorant de 15,1 à 2,5. Plus précisément, 58,6% des participants à la dose de 40 mg et 59,5% à la dose de 80 mg ont atteint la rémission. Le traitement s'est avéré efficace dans divers diagnostics psychiatriques, avec 57,7% des patients atteints de schizophrénie/trouble schizo-affectif et 62,5% des patients présentant des troubles de l'humeur atteignant les seuils de rémission.
Neurocrine Biosciences (NBIX) hat neue Langzeitdaten aus der KINECT® 4-Studie präsentiert, die signifikante Remissionsraten bei Patienten mit tardiver Dyskinesie zeigen, die mit INGREZZA® (Valbenazin) behandelt wurden. Die 48-wöchige Studie umfasste 103 Teilnehmer und zeigte, dass 59,2% eine Remission erreichten, mit konsistenten Ergebnissen über verschiedene Dosen und psychiatrische Erkrankungen hinweg.
Die Studie zeigte bemerkenswerte Verbesserungen der AIMS-Punkte, wobei Patienten mit einer Dosis von 40 mg eine Punktzahl von 12,4 auf 2,1 senkten und Patienten mit einer Dosis von 80 mg von 15,1 auf 2,5 verbesserten. Konkret erreichten 58,6% der Teilnehmer mit der 40-mg-Dosis und 59,5% mit der 80-mg-Dosis eine Remission. Die Behandlung erwies sich als wirksam bei verschiedenen psychiatrischen Diagnosen, wobei 57,7% der Patienten mit Schizophrenie/schizoaffektiver Störung und 62,5% der Patienten mit affektiven Störungen die Remissionsschwellen erreichten.
- Strong efficacy demonstrated with 59.2% overall remission rate in tardive dyskinesia patients
- Significant AIMS score improvements from baseline to Week 48 across both dosage groups
- Consistent effectiveness across different psychiatric conditions showing broad applicability
- Positive results achieved even at lowest dose (40 mg)
- 40.8% of patients did not achieve remission despite 48 weeks of treatment
Insights
Neurocrine's latest INGREZZA data strengthens its position in the tardive dyskinesia (TD) market with impressive long-term efficacy results. The 48-week KINECT 4 study demonstrated that 59.2% of participants achieved clinical remission, with consistent results across both dose levels (58.6% at 40mg and 59.5% at 80mg).
The substantial AIMS score reductions (from baseline scores of 12.4-15.1 to just 2.1-2.5 at Week 48) represent meaningful clinical improvement for patients. Particularly significant is the equivalent efficacy at the lower 40mg dose, potentially allowing for effective treatment while minimizing side effects.
These results provide important differentiation in the TD treatment landscape by demonstrating consistent efficacy across patient subgroups regardless of underlying psychiatric condition. For Neurocrine, this data reinforces INGREZZA's clinical profile as their flagship product and primary revenue driver.
While the open-label, post-hoc nature of this analysis has inherent limitations compared to controlled trials, the magnitude and consistency of benefit over 48 weeks suggests durable efficacy that should support continued physician confidence in prescribing INGREZZA for long-term TD management.
- Majority of Participants Reached a Defined Threshold for Remission of Tardive Dyskinesia Regardless of Underlying Psychiatric Disorder
- Findings Presented at the 2025 Psychiatry Update Conference
"These findings further establish INGREZZA as a highly effective long-term treatment option for individuals living with tardive dyskinesia, regardless of their underlying psychiatric condition, including schizophrenia, schizoaffective disorder or mood disorder," said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences. "The significant improvements observed in AIMS score and the high remission rates highlight the efficacy of INGREZZA, at even the lowest dose."
The post-hoc analysis was conducted using data from 103 participants who reached the final Week 48 visit in the KINECT 4 clinical trial and assessed a proposed threshold for remission of tardive dyskinesia (TD) symptoms using the Abnormal Involuntary Movement Scale (AIMS). The threshold for remission was defined as an AIMS item score of ≤1 (rating of "none" or "minimal") in each of the seven body regions (items 1-7). The percentage who met the threshold for remission was analyzed by dose (40 mg and 80 mg) and by psychiatric diagnosis (schizophrenia or schizoaffective disorder, mood disorder).
A majority of participants who received 48 weeks of once-daily INGREZZA reached the threshold for remission of TD while on treatment, regardless of underlying psychiatric diagnosis or dose:
59.2% (61/103) of participants who completed the study achieved remission, including58.6% (17/29) of participants on the 40 mg dose and59.5% (44/74) of participants on the 80 mg dose.- Both 40 mg and 80 mg doses of INGREZZA showed significant improvements in AIMS total scores, with mean baseline scores of 12.4 (40 mg) and 15.1 (80 mg) decreasing to 2.1 and 2.5, respectively, at Week 48.
- Remission rates were consistent across psychiatric diagnoses, with
57.7% (41/71) of participants with schizophrenia or schizoaffective disorder and62.5% (20/32) of participants with mood disorders achieving remission.
Additional poster presentation at the 2025 Psychiatry Update Conference includes:
- Substantial Long-Term Improvements in Tardive Dyskinesia With Valbenazine 40 mg
About the KINECT® 4 Phase 3 Study
KINECT 4 is a Phase 3, 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. Participants were discontinued if the new dose was not tolerated.
Participants experienced TD improvements during long-term treatment as demonstrated by mean change from baseline to Week 48 in AIMS total score (sum of items 1-7, evaluated by site raters) with INGREZZA 40 mg/day (-10.2) or 80 mg/day (-11.0). Consistent with previous studies, INGREZZA was generally well tolerated. After Week 4, treatment emergent adverse events (TEAEs) that occurred in ≥
About Tardive Dyskinesia
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 (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 severe and are often persistent and irreversible. TD is estimated to affect at least 800,000 adults in the U.S.
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:
- 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 LinkedIn, X and Facebook. (*in collaboration with AbbVie)
The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, KINECT and INGREZZA are registered 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 annual report on Form 10-K for the year ended December 31, 2024. 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-0050 03/2025
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FAQ
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