Neurocrine Biosciences Publishes Analysis Showing Long-Term Efficacy and a Consistent Safety Profile of INGREZZA® (valbenazine) Capsules in Older Adults with Tardive Dyskinesia in The Journal of Clinical Psychiatry
Neurocrine Biosciences (NBIX) has published a groundbreaking post-hoc analysis in The Journal of Clinical Psychiatry, demonstrating INGREZZA's long-term efficacy and safety in treating tardive dyskinesia (TD) in adults aged 65 and older.
The analysis, pooling data from two 48-week studies (KINECT 3 extension and KINECT 4), included 304 participants, with 55 (18.1%) aged ≥65 years. Key findings show that older adults achieved substantial TD symptom improvements within 8 weeks, sustained through 48 weeks:
- 95% of patients on INGREZZA 80mg showed ≥30% improvement in AIMS scores
- 95% on 80mg demonstrated CGI-TD improvements
- 90% on 80mg reported PGIC improvements
The safety profile remained consistent with no new treatment-emergent adverse events of clinical concern compared to younger adults. Common side effects included urinary tract infection and somnolence, each affecting 6 of 55 older participants.
Neurocrine Biosciences (NBIX) ha pubblicato un'analisi post-hoc innovativa su The Journal of Clinical Psychiatry, dimostrando l'efficacia e la sicurezza a lungo termine di INGREZZA nel trattamento della discinesia tardiva (TD) in adulti di età pari o superiore a 65 anni.
L'analisi, che ha unito i dati di due studi di 48 settimane (prolungamento di KINECT 3 e KINECT 4), ha coinvolto 304 partecipanti, di cui 55 (18,1%) con età ≥65 anni. I risultati principali evidenziano che gli anziani hanno ottenuto miglioramenti significativi nei sintomi della TD entro 8 settimane, mantenuti fino a 48 settimane:
- Il 95% dei pazienti trattati con INGREZZA 80 mg ha mostrato un miglioramento ≥30% nei punteggi AIMS
- Il 95% con 80 mg ha evidenziato miglioramenti nella CGI-TD
- Il 90% con 80 mg ha riportato miglioramenti nel PGIC
Il profilo di sicurezza è rimasto stabile, senza nuovi eventi avversi emergenti di rilievo clinico rispetto ai pazienti più giovani. Gli effetti collaterali più comuni sono stati infezioni del tratto urinario e sonnolenza, ciascuno riscontrato in 6 dei 55 partecipanti anziani.
Neurocrine Biosciences (NBIX) ha publicado un análisis post-hoc innovador en The Journal of Clinical Psychiatry, demostrando la eficacia y seguridad a largo plazo de INGREZZA en el tratamiento de la discinesia tardía (TD) en adultos de 65 años o más.
El análisis, que combinó datos de dos estudios de 48 semanas (extensión de KINECT 3 y KINECT 4), incluyó a 304 participantes, de los cuales 55 (18,1%) tenían ≥65 años. Los hallazgos clave muestran que los adultos mayores lograron mejoras sustanciales en los síntomas de TD dentro de las 8 semanas, mantenidas hasta las 48 semanas:
- El 95% de los pacientes con INGREZZA 80 mg mostró una mejora ≥30% en las puntuaciones AIMS
- El 95% con 80 mg demostró mejoras en CGI-TD
- El 90% con 80 mg reportó mejoras en PGIC
El perfil de seguridad se mantuvo consistente, sin nuevos eventos adversos emergentes de preocupación clínica en comparación con adultos más jóvenes. Los efectos secundarios comunes incluyeron infección del tracto urinario y somnolencia, cada uno afectando a 6 de los 55 participantes mayores.
Neurocrine Biosciences (NBIX)는 The Journal of Clinical Psychiatry에 획기적인 사후 분석 결과를 발표하며, 65세 이상 성인의 지연성 운동장애(TD) 치료에 있어 INGREZZA의 장기 효능과 안전성을 입증했습니다.
이 분석은 두 건의 48주 연구(KINECT 3 연장 및 KINECT 4)의 데이터를 통합했으며, 총 304명의 참가자 중 55명(18.1%)이 65세 이상이었습니다. 주요 결과는 고령 환자들이 8주 이내에 TD 증상에서 상당한 개선을 이루었고, 48주까지 유지되었음을 보여줍니다:
- INGREZZA 80mg 투여 환자의 95%가 AIMS 점수에서 30% 이상의 개선을 보임
- 80mg 투여군의 95%가 CGI-TD에서 개선을 나타냄
- 80mg 투여군의 90%가 PGIC에서 개선을 보고함
안전성 프로필은 젊은 성인과 비교해 임상적으로 우려되는 새로운 치료 관련 이상반응 없이 일관되게 유지되었습니다. 흔한 부작용으로는 요로감염과 졸음이 있었으며, 각각 55명의 고령 참가자 중 6명에게서 발생했습니다.
Neurocrine Biosciences (NBIX) a publié une analyse post-hoc révolutionnaire dans The Journal of Clinical Psychiatry, démontrant l'efficacité et la sécurité à long terme de INGREZZA dans le traitement de la dyskinésie tardive (TD) chez les adultes âgés de 65 ans et plus.
L'analyse, regroupant les données de deux études de 48 semaines (extension de KINECT 3 et KINECT 4), a inclus 304 participants, dont 55 (18,1 %) âgés de ≥65 ans. Les résultats clés montrent que les personnes âgées ont obtenu des améliorations substantielles des symptômes de la TD dès 8 semaines, maintenues jusqu'à 48 semaines :
- 95 % des patients sous INGREZZA 80 mg ont présenté une amélioration ≥30 % des scores AIMS
- 95 % sous 80 mg ont démontré des améliorations sur la CGI-TD
- 90 % sous 80 mg ont rapporté des améliorations sur le PGIC
Le profil de sécurité est resté stable, sans nouveaux événements indésirables émergents cliniquement préoccupants par rapport aux adultes plus jeunes. Les effets secondaires courants comprenaient des infections urinaires et de la somnolence, chacun affectant 6 des 55 participants âgés.
Neurocrine Biosciences (NBIX) hat eine bahnbrechende Post-hoc-Analyse im The Journal of Clinical Psychiatry veröffentlicht, die die langfristige Wirksamkeit und Sicherheit von INGREZZA bei der Behandlung der tardiven Dyskinesie (TD) bei Erwachsenen ab 65 Jahren belegt.
Die Analyse, die Daten aus zwei 48-wöchigen Studien (KINECT 3 Verlängerung und KINECT 4) zusammenfasste, umfasste 304 Teilnehmer, davon 55 (18,1 %) im Alter von ≥65 Jahren. Wichtige Ergebnisse zeigen, dass ältere Erwachsene innerhalb von 8 Wochen erhebliche Verbesserungen der TD-Symptome erzielten, die bis zu 48 Wochen anhielten:
- 95 % der Patienten mit INGREZZA 80 mg zeigten eine Verbesserung der AIMS-Werte um ≥30 %
- 95 % der 80-mg-Gruppe zeigten Verbesserungen im CGI-TD
- 90 % der 80-mg-Gruppe berichteten über Verbesserungen im PGIC
Das Sicherheitsprofil blieb konsistent, ohne neue behandlungsbedingte unerwünschte Ereignisse von klinischer Bedeutung im Vergleich zu jüngeren Erwachsenen. Häufige Nebenwirkungen waren Harnwegsinfektionen und Schläfrigkeit, die jeweils 6 der 55 älteren Teilnehmer betrafen.
- High efficacy rates with 95% response in elderly patients on 80mg dose
- Strong safety profile with no new adverse events in elderly population
- Sustained therapeutic effect demonstrated through 48 weeks
- First peer-reviewed analysis of VMAT2 inhibitor for elderly TD patients
- elderly patient sample size (only 55 patients ≥65 years)
- Some adverse events reported (UTI and somnolence) in elderly population
Insights
Peer-reviewed publication validates INGREZZA's efficacy and safety in older adults with tardive dyskinesia, strengthening its clinical profile in this vulnerable population.
This publication in The Journal of Clinical Psychiatry represents an important addition to INGREZZA's clinical evidence base. The post-hoc analysis from two 48-week studies (KINECT 3 extension and KINECT 4) demonstrated substantial and sustained improvements in tardive dyskinesia symptoms among adults aged 65 years and older, with no new safety concerns compared to younger patients.
The data is particularly significant because older adults are at higher risk for developing TD, potentially after just one month of exposure to antipsychotics. The involuntary movements of TD can significantly impact older adults' balance, gait, swallowing ability, and respiratory function.
The efficacy results are compelling:
As the first and only peer-reviewed analysis of a VMAT2 inhibitor in older adults with TD, this publication addresses an important research gap. The consistent safety profile, with psychiatric stability maintained throughout the 48-week treatment period, is particularly relevant for this vulnerable population where medication tolerability concerns often influence prescribing decisions.
This data strengthens INGREZZA's clinical profile in a key demographic and may help maintain its position in the TD treatment landscape by providing physicians with greater confidence when prescribing to older patients.
Publication strengthens INGREZZA's market position in the growing TD treatment space, particularly for the high-risk geriatric patient segment.
This peer-reviewed publication provides Neurocrine with valuable clinical evidence supporting INGREZZA's use in older adults with tardive dyskinesia. INGREZZA serves as Neurocrine's primary commercial driver, making any data that potentially expands or strengthens its market position particularly relevant.
The geriatric patient population represents a significant market segment for TD treatments, as older adults are more susceptible to developing this condition. The robust efficacy results—
Being positioned as the first and only published analysis of its kind offers Neurocrine a potential competitive advantage in the TD treatment landscape. This differentiation may be particularly valuable for influencing prescribing patterns among geriatric psychiatrists, neurologists, and other specialists who treat older patients with TD.
While this publication represents incremental rather than revolutionary clinical evidence, such peer-reviewed data cumulatively helps reinforce INGREZZA's market position and potentially supports continued prescription growth in this important patient segment. The timing of this publication also aligns with broader industry trends toward greater focus on geriatric medicine as the population ages.
This type of targeted clinical evidence addressing specific high-risk populations demonstrates Neurocrine's continued commitment to expanding INGREZZA's evidence base and maintaining its competitive position in the TD treatment market.
Post-hoc analysis of higher risk older adults showed substantial and sustained improvements in tardive dyskinesia symptoms with no new treatment-emergent adverse events of clinical concern
Individuals aged 60 years and older may develop TD after as little as one month of exposure to antipsychotics and other dopamine receptor blocking agents. The involuntary movements of TD can also have a substantial impact on older adults, affecting their balance, gait, ability to swallow and respiratory conditions. The data from this post-hoc analysis show substantial and sustained improvements in TD symptoms in older adults, with no new treatment-emergent adverse events of clinical concern found when compared with younger adults (<65 years).
"This analysis, the first and only of its kind in a peer-reviewed publication, addresses an important gap in research on this potentially vulnerable population," said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences. "These data show that participants 65 years and older achieved clinically meaningful improvements in tardive dyskinesia symptoms within eight weeks of INGREZZA treatment, with substantial and sustained improvement up to 48 weeks, adding to the breadth of evidence suggesting INGREZZA is uniquely suitable for this patient population."
The pooled post-hoc analysis included 304 participants across studies who received a once-daily dose of INGREZZA (40 mg or 80 mg) for up to 48 weeks. Of the total participants, 55 (
The efficacy of INGREZZA was assessed using mean changes from baseline in the Abnormal Involuntary Movement Scale (AIMS) total score, AIMS response thresholds (≥
Data from this analysis of participants ≥65 years in the KINECT 3 extension and KINECT 4 studies suggest substantial and sustained improvements in TD symptoms with INGREZZA treatment (all doses):
AIMS threshold ≥ | CGI-TD scores ≤2 by Week | PGIC scores ≤2 by Week 48* |
*Post-hoc analysis results not adjusted for multiple comparisons. | ||
Overall, psychiatric stability was maintained through 48 weeks of treatment and INGREZZA was generally well tolerated. The most common treatment-emergent adverse events reported from Weeks 8 to 48 included urinary tract infection and somnolence; each occurred in six of the 55 participants who were 65 years and older.
There were no statistically significant differences between age groups (<65 versus ≥65) for most efficacy and safety outcomes at Week 48.
About the KINECT® 3 Phase 3 Study
KINECT 3 is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in which 234 participants with moderate to severe TD and underlying schizophrenia, schizoaffective disorder or mood disorder (including bipolar disorder or major depressive disorder) received six weeks of once-daily INGREZZA (40 mg or 80 mg capsules) or placebo (participants randomized to 80 mg started on 40 mg for one week). Subsequent to the completion of the six-week placebo-controlled dosing, participants receiving INGREZZA continued on their current dose and placebo participants were randomized to receive either once-daily 40 mg or once-daily 80 mg of INGREZZA, through Week 48 (42-week blinded treatment extension period; placebo participants randomized to 80 mg started on 40 mg for one week), followed by a four-week, drug-free washout. Dose reduction to 40 mg was allowed for participants who were unable to tolerate the 80 mg dose. Patients were discontinued if the new dose was not tolerated.
The study met its primary endpoint of change-from-baseline in AIMS at Week 6 in the 80 mg once-daily dosing group compared with placebo as assessed by expert central blinded video raters. The mean change from baseline to Week 6 in the AIMS rating was -3.2 for the 80 mg once-daily group as compared with -0.1 in the placebo group (P>0.0001). Sustained TD improvements were seen with INGREZZA 40 mg and 80 mg through Week 48.
INGREZZA was generally well tolerated throughout 48 weeks of treatment. The most common adverse reactions (≥
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 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 mild to 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 neurocrine.com, and follow the company on 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-0058 04/2025
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FAQ
What are the efficacy rates of INGREZZA 80mg in elderly TD patients after 48 weeks?
How many elderly patients were included in NBIX's INGREZZA clinical studies?
What are the main side effects of INGREZZA in elderly TD patients?
How quickly do elderly patients see improvements with INGREZZA for TD symptoms?
