Neurocrine Biosciences Presents New Data on INGREZZA® (valbenazine) Capsules at Psych Congress 2024: Majority of Long-Term Study Participants Achieved Remission of Tardive Dyskinesia
Neurocrine Biosciences (NBIX) presented promising long-term data for INGREZZA® (valbenazine) at Psych Congress 2024, showing 59.2% of participants achieved tardive dyskinesia remission at Week 48. The KINECT®-4 study, involving 103 participants, demonstrated that 65% of patients in the 40mg dose group and 57.8% in the 80mg dose group reached remission threshold. Notably, 10% of participants achieved complete resolution with a total AIMS score of 0. The study defined remission as having minimal or no symptoms across all body regions measured by the Abnormal Involuntary Movement Scale.
Neurocrine Biosciences (NBIX) ha presentato dati promettenti a lungo termine per INGREZZA® (valbenazina) al Congresso di Psicologia 2024, mostrando che il 59,2% dei partecipanti ha raggiunto la remissione dalla discinesia tardiva alla Settimana 48. Lo studio KINECT®-4, che ha coinvolto 103 partecipanti, ha dimostrato che il 65% dei pazienti nel gruppo da 40 mg e il 57,8% nel gruppo da 80 mg hanno raggiunto il soglia di remissione. È importante notare che il 10% dei partecipanti ha ottenuto una risoluzione completa con un punteggio totale AIMS di 0. Lo studio ha definito la remissione come l'avere sintomi minimi o assenti in tutte le aree del corpo misurate dalla Scala dei Movimenti Involontari Anomali.
Neurocrine Biosciences (NBIX) presentó datos prometedores a largo plazo para INGREZZA® (valbenazina) en el Congreso de Psicología 2024, mostrando que el 59,2% de los participantes logró la remisión de la discinesia tardiva a la Semana 48. El estudio KINECT®-4, que involucró a 103 participantes, demostró que el 65% de los pacientes en el grupo de 40 mg y el 57,8% en el grupo de 80 mg alcanzaron el umbral de remisión. Notablemente, el 10% de los participantes logró una resolución completa con un puntaje total de AIMS de 0. El estudio definió la remisión como tener síntomas mínimos o nulos en todas las regiones del cuerpo medidos por la Escala de Movimientos Involuntarios Anormales.
Neurocrine Biosciences (NBIX)는 2024년 심리학 회의에서 INGREZZA® (발베나진)의 장기 데이터에 대한 유망한 결과를 발표했으며, 참가자의 59.2%가 48주차에 지연성 운동이상증의 관해를 달성했습니다. 103명이 참여한 KINECT®-4 연구에서는 40mg 복용 그룹에서 65%의 환자와 80mg 복용 그룹에서 57.8%가 관해 기준에 도달한 것으로 나타났습니다. 특히, 참가자의 10%가 AIMS 총 점수가 0으로 완전한 해소를 달성했습니다. 이 연구는 AIMS(비정상적 비자발적 운동 척도)로 측정된 모든 신체 부위에서 증상이 최소한이거나 전혀 없는 경우를 관해로 정의했습니다.
Neurocrine Biosciences (NBIX) a présenté des données prometteuses à long terme pour INGREZZA® (valbénazine) lors du Congrès de Psychologie 2024, montrant que 59,2% des participants ont atteint une rémission de la dyskinésie tardive à la Semaine 48. L'étude KINECT®-4, impliquant 103 participants, a démontré que 65% des patients du groupe de dosage de 40 mg et 57,8% du groupe de 80 mg ont atteint le seuil de rémission. Notamment, 10% des participants ont obtenu une résolution complète avec un score AIMS total de 0. L'étude a défini la rémission comme le fait d'avoir des symptômes minimes ou absents dans toutes les régions du corps mesurées par l'Échelle des Mouvements Involontaires Anormaux.
Neurocrine Biosciences (NBIX) hat auf dem Psych Congress 2024 vielversprechende Langzeitdaten für INGREZZA® (Valbenazin) präsentiert und gezeigt, dass 59,2% der Teilnehmer bis Woche 48 eine Remission der tardiven Dyskinesie erreichten. Die KINECT®-4-Studie, an der 103 Teilnehmer teilnahmen, zeigte, dass 65% der Patienten in der 40-mg-Dosierungsgruppe und 57,8% in der 80-mg-Dosierungsgruppe den Remissionsschwellenwert erreichten. Bemerkenswert ist, dass 10% der Teilnehmer eine vollständige Auflösung mit einem Gesamtaims-Wert von 0 erreichten. Die Studie definierte Remission als das Vorhandensein von minimalen oder keinen Symptomen in allen Körperregionen, die mit der Abnormal Involuntary Movement Scale gemessen wurden.
- 59.2% of study participants achieved tardive dyskinesia remission at Week 48
- 10% of participants reached complete symptom resolution (AIMS score of 0)
- High remission rates across both dosage groups (65% for 40mg, 57.8% for 80mg)
- None.
Insights
The long-term KINECT-4 study results demonstrate significant clinical efficacy for INGREZZA, Neurocrine's flagship tardive dyskinesia treatment. The
- Strong efficacy across severity levels, with remission achieved in
64.3% of moderate cases and53.5% of severe cases - Complete symptom resolution (AIMS score of 0) in
10% of participants - Consistent performance across both 40mg and 80mg dosing groups (
65.0% and57.8% remission rates respectively)
These results strengthen INGREZZA's market position as a leading TD treatment, particularly important given TD's irreversible nature and significant impact on patient quality of life. The robust remission data could drive increased adoption among psychiatrists and neurologists, potentially expanding market share.
"Tardive dyskinesia is persistent and irreversible, and effective treatment over time can have a positive impact for patients who are already living with underlying psychotic and mood disorders," said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences. "Our clinical studies have shown clinically meaningful and sustained improvement in tardive dyskinesia with INGREZZA, and these remission data add to the body of evidence characterizing the robust impact of INGREZZA treatment."
This post hoc analysis was conducted using data from 103 participants who reached the final Week 48 visit in the open-label KINECT-4 clinical trial.
Remission was defined as having a score of 1 or less (rating of "none" or "minimal") in each body region (items 1-7) on the Abnormal Involuntary Movement Scale (AIMS). Shifts to remission were defined as a maximum item score of 2 ("mild"), 3 ("moderate") or 4 ("severe") at baseline and each item score of 1 or less at Week 48.
Treatment with INGREZZA resulted in tardive dyskinesia (TD) symptom remission for the majority of patients at Week 48:
59.2% (61/103) of participants had a score of 1 or less in each AIMS item.65.0% (13/20) of participants in the 40 mg dose group and57.8% (48/83) of participants in the 80 mg dose group met this remission threshold.
10% (10/103) of participants had complete resolution, with a total AIMS score of 0.- Of the 4 participants with a maximum item score of 2 at baseline,
50.0% (2/4) reached the remission threshold. - Of the 56 participants with a maximum item score of 3 at baseline,
64.3% (36/56) reached the remission threshold. - Of the 43 participants with a maximum item score of 4 at baseline,
53.5% (23/43) reached the remission threshold.
Additional Neurocrine Biosciences posters presented at Psych Congress 2024 include:
- Once-Daily Valbenazine for Tardive Dyskinesia or
Huntington's Disease Chorea in Patients with Dysphagia or Swallowing Difficulties (Poster #114) - A Multi-Year Survey on United States Psychiatry Clinicians: Trends on Managing Patients with Tardive Dyskinesia (Poster #48)
- Item Response Theory (IRT) Analyses of the Tardive Dyskinesia Impact Scale (TDIS) (Poster #28)
- Impact of Valbenazine on Physical, Psychological, and Functional Health in Patients with Tardive Dyskinesia: Results of EQ-5D-5L Health State Scores from 16 Weeks of Valbenazine Treatment (Poster #29)
- Real World Improvement in Quality of Life and Functional Status of Valbenazine-Treated Patients With Tardive Dyskinesia From a 2024 Chart Extraction and Clinician Survey of 164 Patients (Poster #27)
- Treatment Effect Sizes of Once-Daily Valbenazine for Tardive Dyskinesia and for Chorea Associated with
Huntington's Disease: A Post Hoc Analysis of Phase 3 Clinical Trial Data (Poster #44)
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. Patients 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 (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 (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 approximately 800,000 people in the U.S.
About Chorea Associated with Huntington's Disease (HD)
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 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 ofHuntington'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
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 effect 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
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, 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, chorea associated with
The NEUROCRINE BIOSCIENCES Logo Lockup, 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; risks that clinical trial activities may not be predictive of real-world results or of results in subsequent clinical trials; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities related to INGREZZA and our product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that our products, and/or our product candidates 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; risks associated with potential generic entrants for our products; 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 September 30, 2024. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law.
© 2024 Neurocrine Biosciences, Inc. All Rights Reserved
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FAQ
What percentage of patients achieved tardive dyskinesia remission with INGREZZA (NBIX) in the KINECT-4 study?
How many patients achieved complete symptom resolution in the INGREZZA KINECT-4 study?
What were the remission rates for different INGREZZA doses in the 2024 KINECT-4 study?
