Neurocrine Biosciences Presents Real-World Data on Therapeutic Dose Attainment and Dosing Trends of VMAT2 Inhibitors in Patients With Tardive Dyskinesia
Neurocrine Biosciences (NBIX) presented new real-world data comparing therapeutic dose attainment between INGREZZA and deutetrabenazine in tardive dyskinesia treatment. The retrospective study (2022-2024) analyzed 3,527 INGREZZA patients, 2,166 deutetrabenazine BID patients, and 326 deutetrabenazine XR patients.
Key findings showed that 100% of INGREZZA patients reached therapeutic doses from day one, while only 47.5% of deutetrabenazine BID and 54.3% of deutetrabenazine XR patients achieved therapeutic doses within six months. Among deutetrabenazine patients who reached therapeutic doses, nearly 10% couldn't maintain them.
The study also revealed that INGREZZA patients experienced fewer dose changes (33.7%) compared to deutetrabenazine patients (BID: 48.1%; XR: 54.0%) after the first month of treatment.
Neurocrine Biosciences (NBIX) ha presentato nuovi dati reali che confrontano il raggiungimento della dose terapeutica tra INGREZZA e deutetrabenazina nel trattamento della discinesia tardiva. Lo studio retrospettivo (2022-2024) ha analizzato 3.527 pazienti trattati con INGREZZA, 2.166 pazienti trattati con deutetrabenazina BID e 326 pazienti trattati con deutetrabenazina XR.
I risultati chiave hanno mostrato che il 100% dei pazienti trattati con INGREZZA ha raggiunto dosi terapeutiche sin dal primo giorno, mentre solo il 47,5% dei pazienti trattati con deutetrabenazina BID e il 54,3% dei pazienti trattati con deutetrabenazina XR hanno raggiunto dosi terapeutiche entro sei mesi. Tra i pazienti trattati con deutetrabenazina che hanno raggiunto dosi terapeutiche, quasi il 10% non è riuscito a mantenerle.
Lo studio ha anche rivelato che i pazienti trattati con INGREZZA hanno sperimentato meno cambiamenti di dose (33,7%) rispetto ai pazienti trattati con deutetrabenazina (BID: 48,1%; XR: 54,0%) dopo il primo mese di trattamento.
Neurocrine Biosciences (NBIX) presentó nuevos datos del mundo real que comparan la obtención de dosis terapéuticas entre INGREZZA y deutetrabenazina en el tratamiento de la discinesia tardía. El estudio retrospectivo (2022-2024) analizó a 3,527 pacientes tratados con INGREZZA, 2,166 pacientes tratados con deutetrabenazina BID y 326 pacientes tratados con deutetrabenazina XR.
Los hallazgos clave mostraron que el 100% de los pacientes tratados con INGREZZA alcanzaron dosis terapéuticas desde el primer día, mientras que solo el 47.5% de los pacientes tratados con deutetrabenazina BID y el 54.3% de los pacientes tratados con deutetrabenazina XR lograron dosis terapéuticas en seis meses. Entre los pacientes tratados con deutetrabenazina que alcanzaron dosis terapéuticas, casi el 10% no pudo mantenerlas.
El estudio también reveló que los pacientes tratados con INGREZZA experimentaron menos cambios de dosis (33.7%) en comparación con los pacientes tratados con deutetrabenazina (BID: 48.1%; XR: 54.0%) después del primer mes de tratamiento.
Neurocrine Biosciences (NBIX)는 지연성 운동장애 치료에서 INGREZZA와 deutetrabenazine 간의 치료 용량 도달을 비교한 새로운 실제 데이터를 발표했습니다. 이 회고적 연구(2022-2024)는 3,527명의 INGREZZA 환자, 2,166명의 deutetrabenazine BID 환자 및 326명의 deutetrabenazine XR 환자를 분석했습니다.
주요 발견은 INGREZZA 환자의 100%가 첫날부터 치료 용량에 도달한 반면, deutetrabenazine BID 환자의 47.5%와 deutetrabenazine XR 환자의 54.3%만이 6개월 이내에 치료 용량에 도달했다는 것입니다. 치료 용량에 도달한 deutetrabenazine 환자 중 거의 10%는 이를 유지하지 못했습니다.
이 연구는 또한 INGREZZA 환자가 치료 첫 달 이후 더 적은 용량 변경을 경험했다는 것을 보여주었습니다 (33.7%) 반면, deutetrabenazine 환자는 (BID: 48.1%; XR: 54.0%)였습니다.
Neurocrine Biosciences (NBIX) a présenté de nouvelles données du monde réel comparant l'atteinte de doses thérapeutiques entre INGREZZA et deutetrabenazine dans le traitement de la dyskinésie tardive. L'étude rétrospective (2022-2024) a analysé 3 527 patients traités par INGREZZA, 2 166 patients traités par deutetrabenazine BID et 326 patients traités par deutetrabenazine XR.
Les résultats clés ont montré que 100% des patients traités par INGREZZA ont atteint des doses thérapeutiques dès le premier jour, tandis que seulement 47,5% des patients traités par deutetrabenazine BID et 54,3% des patients traités par deutetrabenazine XR ont atteint des doses thérapeutiques dans les six mois. Parmi les patients traités par deutetrabenazine ayant atteint des doses thérapeutiques, près de 10% n'ont pas pu les maintenir.
L'étude a également révélé que les patients traités par INGREZZA ont connu moins de changements de dose (33,7%) par rapport aux patients traités par deutetrabenazine (BID : 48,1 % ; XR : 54,0 %) après le premier mois de traitement.
Neurocrine Biosciences (NBIX) hat neue Daten aus der realen Welt präsentiert, die die Erreichung therapeutischer Dosen zwischen INGREZZA und Deutetrabenazin bei der Behandlung von tardiven Dyskinesien vergleichen. Die retrospektive Studie (2022-2024) analysierte 3.527 Patienten, die mit INGREZZA behandelt wurden, 2.166 Patienten, die mit Deutetrabenazin BID behandelt wurden, und 326 Patienten, die mit Deutetrabenazin XR behandelt wurden.
Wichtige Ergebnisse zeigten, dass 100% der Patienten, die mit INGREZZA behandelt wurden, von Tag eins an therapeutische Dosen erreichten, während nur 47,5% der Patienten, die mit Deutetrabenazin BID behandelt wurden, und 54,3% der Patienten, die mit Deutetrabenazin XR behandelt wurden, innerhalb von sechs Monaten therapeutische Dosen erreichten. Unter den Deutetrabenazin-Patienten, die therapeutische Dosen erreichten, konnten fast 10% diese nicht aufrechterhalten.
Die Studie ergab auch, dass INGREZZA-Patienten weniger Dosisänderungen erlebten (33,7%) im Vergleich zu Deutetrabenazin-Patienten (BID: 48,1%; XR: 54,0%) nach dem ersten Monat der Behandlung.
- 100% of INGREZZA patients reached therapeutic dose immediately vs. only ~50% for competitor drug
- INGREZZA showed better dose stability with fewer changes (33.7%) vs. deutetrabenazine (48.1-54.0%)
- Superior maintenance of therapeutic doses compared to competitor with ~10% of deutetrabenazine patients unable to maintain therapeutic levels
- None.
Insights
The real-world data presented by Neurocrine Biosciences highlights significant clinical advantages for INGREZZA over deutetrabenazine in tardive dyskinesia treatment. The study's large sample size (3,527 INGREZZA patients vs 2,166 deutetrabenazine BID and 326 deutetrabenazine XR patients) provides robust evidence of superior dose optimization.
The finding that 100% of INGREZZA patients reached therapeutic dosing on day one versus only 47.5% of deutetrabenazine BID and 54.3% of deutetrabenazine XR patients achieving this within six months represents a substantial clinical advantage. This 3-4 week faster therapeutic onset could translate to quicker symptom relief for patients suffering from this debilitating condition.
Equally telling is that nearly 10% of deutetrabenazine patients couldn't maintain therapeutic dosing despite continuing treatment. This suggests potential efficacy challenges with competitor products in real-world settings. The significantly lower rate of dose changes with INGREZZA (33.7% vs 48.1% for BID and 54.0% for XR) demonstrates a more stable dosing profile that simplifies treatment protocols.
These advantages address a crucial clinical pain point - achieving and maintaining effective treatment levels in tardive dyskinesia. For a neurological condition with approved therapies, these differentiated benefits could strengthen INGREZZA's position as a preferred treatment option.
This real-world data substantially strengthens INGREZZA's competitive positioning in the tardive dyskinesia market. The immediate therapeutic dosing capability eliminates the titration period required by deutetrabenazine, creating a meaningful differentiation point that resonates with both clinicians and payers.
From a prescriber perspective, the simplified dosing approach reduces treatment complexity and monitoring requirements. Dr. Roberts highlights this as reducing "clinician and patient burden associated with sub-therapeutic dosing" - a benefit that could drive preference among neurologists and psychiatrists managing these patients.
For payers and formulary decision-makers, the data presents a compelling value proposition. The immediate achievement of therapeutic dosing potentially translates to faster symptom control and fewer medication adjustments, which could improve adherence and reduce healthcare resource utilization.
The study's comprehensive design using longitudinal prescription data across a significant patient population (over 6,000 combined patients) adds credibility to these findings. The statistical significance (P<0.001) of the dosing differences further validates INGREZZA's advantages.
This data reinforces Neurocrine's competitive position at a critical time when treatment options for tardive dyskinesia are expanding. By demonstrating clear advantages in dosing efficiency and maintenance, INGREZZA solidifies its clinical differentiation in this specialized market.
- All Patients Treated with INGREZZA® (valbenazine) Capsules Reached a Therapeutic Dose from Day One, While Only Approximately Half of Patients Treated with Deutetrabenazine Were Able to Reach a Therapeutic Dose Within Six Months
- Findings Presented at the Academy of Managed Care Pharmacy 2025 Annual Meeting
"These findings provide critical insights into the real-world use of VMAT2 inhibitors in treating tardive dyskinesia," said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences. "Significant differences were observed between INGREZZA and deutetrabenazine in reaching therapeutic doses. The data showed INGREZZA provides a therapeutic dose from day one, without the need for titration, potentially reducing the clinician and patient burden associated with sub-therapeutic dosing."
The retrospective cohort study used data from IQVIA's longitudinal prescription and professional fee claims
Throughout the six-month follow-up period, patients experienced dose changes according to their treatment needs in the course of real-world clinical practice. Therapeutic dosing threshold was defined as the lowest dose showing clinical efficacy per controlled clinical trial data (deutetrabenazine 24 mg/day and INGREZZA 40 mg/day). Results showed:
- All patients treated with INGREZZA at 40 mg, 60 mg or 80 mg reached a therapeutic dose upon initiation of treatment, while significantly fewer deutetrabenazine-treated patients were able to reach a therapeutic dose within six months.
- Only
47.5% of patients on deutetrabenazine BID and54.3% of patients on deutetrabenazine XR were able to reach a therapeutic dose within six months, with an average attainment time of three to four weeks (P<0.001).- Of those who reached a therapeutic dose, nearly
10% of deutetrabenazine-treated patients stayed on drug but were unable to maintain a therapeutic dose (BID:8.5% ; XR:9.6% ).
- Of those who reached a therapeutic dose, nearly
Dose changes were assessed in patients who persisted on treatment for the full six-month follow-up period without switching agents or having a gap in treatment >45 days (INGREZZA: n=1,856; deutetrabenazine BID: n=1,007; deutetrabenazine XR: n=126). Results showed:
- Fewer patients taking INGREZZA experienced a dose change when compared with those taking deutetrabenazine.
- Significantly more deutetrabenazine-treated patients had a change in dose after the first month of treatment compared with INGREZZA (INGREZZA:
33.7% ; BID:48.1% ; XR:54.0% ; P<0.001).
- Significantly more deutetrabenazine-treated patients had a change in dose after the first month of treatment compared with INGREZZA (INGREZZA:
Additional poster presentation at the Academy of Managed Care Pharmacy 2025 Annual Meeting includes:
- Improvements in Functional Domains, Socio-emotional Domains, and Activities of Daily Living Following Valbenazine Treatment in 315 Patients With Tardive Dyskinesia: Real-world Data From a Chart Extraction and Clinician Survey (Poster #G6)
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
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 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 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
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
The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE 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-0053 03/2025
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FAQ
What percentage of INGREZZA patients reached therapeutic dose compared to deutetrabenazine in the NBIX study?
How many patients were included in the NBIX tardive dyskinesia treatment study?
What percentage of NBIX INGREZZA patients required dose changes compared to deutetrabenazine?
What was the therapeutic dosing threshold for INGREZZA in the NBIX study?
