Neurocrine Biosciences Presents First Expert Consensus Recommendations for Tardive Dyskinesia in Long-Term Care Settings

• Expert panel establishes structured approach to tardive dyskinesia screening, diagnosis and treatment in long-term care, including use of VMAT2 inhibitors
  
  
  
  
• New post-hoc KINECT‑PRO™ analysis in adults aged 65 years and older demonstrates clinically meaningful patient-reported improvements in tardive dyskinesia impact with INGREZZA^® (valbenazine) capsules, reinforcing expert panel recommendations

SAN DIEGO, March 26, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the presentation of the first expert consensus recommendations focused on screening, diagnosis and treatment of tardive dyskinesia among older adults in long-term care settings. Developed through a multidisciplinary Delphi panel, the recommendations address persistent gaps in recognizing and managing tardive dyskinesia in this higher-risk population. Findings were presented at the Society for Post-Acute and Long-Term Care Medical Association (PALTmed) PALTC26 Annual Conference in Anaheim, Calif.

The company also presented a first-of-its-kind post-hoc analysis from the KINECT‑PRO™ study demonstrating meaningful improvements in patient‑reported tardive dyskinesia (TD) impact among adults aged 65 years and older treated with INGREZZA^® (valbenazine) capsules. This analysis adds to the growing body of evidence supporting the appropriateness, efficacy, tolerability and established safety profile of INGREZZA in this patient population.

"To date, there has been limited practical guidance tailored specifically to the screening, diagnosis and treatment of tardive dyskinesia in the long-term care setting," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "The consensus recommendations provide structured guidance for clinicians caring for residents in these environments, and the KINECT-PRO findings demonstrate clinically meaningful patient-reported improvements in the impact of tardive dyskinesia with INGREZZA in adults aged 65 years and older. Together, this guidance and evidence help support more informed treatment decisions in this population that may be at higher risk for tardive dyskinesia."

Older adults in long-term care are at an elevated risk for TD due to prolonged exposure to dopamine receptor blocking agents, advanced age, polypharmacy and complex comorbidities. Recognition and management may be further complicated in residents who are non-ambulatory, cognitively impaired or unable to reliably report symptoms. The Delphi panel was convened to develop recommendations that reflect this clinical complexity and support a more consistent, structured approach to TD care.

"Residents in long-term care settings often present with overlapping medical and psychiatric complexities that can make tardive dyskinesia difficult to consistently recognize and manage," said Amita Patel, M.D., the poster's lead author and psychiatrist at the Joint Township District Memorial Hospital in St. Mary's, Ohio. "Through this process, the panel reached clear consensus on practical, implementable recommendations that support evidence-based diagnosis and appropriate use of VMAT2 inhibitors. These recommendations provide clinicians with a structured framework to guide screening and treatment decisions to help improve outcomes for this especially vulnerable population."

Screening and Diagnosing TD in Long-Term Care Settings Requires a Holistic Approach

The panel identified key considerations to support routine and consistent TD screening in long-term care settings. These include:

• Use of the Abnormal Involuntary Movement Scale (AIMS) for screening and assessing TD.
• Quarterly screening for residents treated with dopamine receptor blocking agents, the primary cause of TD.
• Regular assessment of the impact of TD on residents' well-being, including feedback from residents, family members, caregivers and the broader care team.

Treatment Selection Should Consider Relevant Patient Factors

Panelists also reached consensus that TD should be treated with a vesicular monoamine transporter 2 (VMAT2) inhibitor in long-term care settings and identified several treatment-selection factors particularly relevant in these environments. These include:

• Formulation flexibility for residents who experience dysphagia or difficulty swallowing.
• Simplified administration, including the availability of a therapeutic starting dose.
• Consideration of polypharmacy and potential drug-drug interactions.
• Availability of clinical data in adults aged 65 years and older.

These considerations underscore the importance of selecting a therapy with a clinical profile and administration characteristics that align with the needs of long-term care residents. INGREZZA is approved for the treatment of adults with TD and, among approved VMAT2 inhibitors:

• has been studied extensively in adults aged 65 years and older.
• is the only VMAT2 inhibitor without a cautious dosing recommendation in this population.
• is the only treatment that offers a therapeutic dose from day one with no required titration.
• is available in a sprinkle formulation.
• has a safety profile in adults aged 65 years and older that is consistent with that observed in patients younger than 65 years of age.*

Phase 4 KINECT-PRO Findings Reinforce Significance of Expert Consensus Guidelines

A post-hoc analysis of the KINECT-PRO study complements the consensus recommendations by demonstrating the real-world impact of INGREZZA treatment in older adults. KINECT-PRO is the first and only clinical study to specifically evaluate and investigate patient-reported improvement with INGREZZA for TD using multiple validated scales, including the Tardive Dyskinesia Impact Scale (TDIS™).

In adults aged 65 and older, once-daily INGREZZA was associated with robust patient-reported improvements in TD symptoms, quality of life and functional impairment at Week 24. Patient-reported outcomes also demonstrated reduced social and emotional burden, with improvements in total TDIS scores exceeding the established threshold for clinically meaningful change.

Additional presentations at the Society for Post-Acute and Long-Term Care Medical Association (PALTmed) PALTC26 Annual Conference include: 

• Management of Tardive Dyskinesia in Long-Term Care: Application of the 4Ms Framework
• Physical, Mental, and Socioemotional Functional Improvement Following Valbenazine Treatment in Patients with TD Residing in Long-term Care Settings
• Valbenazine Treatment for Tardive Dyskinesia in a 64-Year-Old Female Presenting with Nonhealing Wounds due to Truncal Dyskinesias: A Case Report

* Safety profiles as demonstrated in a post-hoc analysis from two 48-week studies (KINECT^® 3 extension and KINECT^® 4).

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 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. 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 scales 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 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 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, endocrine, psychiatric and immunological 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, Facebook and YouTube. (*in collaboration with AbbVie)  

The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, KINECT and INGREZZA 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, the interpretation and potential relevance of the data described in this press release, including statements regarding the use and interpretation of the Tardive Dyskinesia Impact Scale (TDIS™), 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 as to whether the data described in this press release will be replicated in additional studies or will be predictive of efficacy or other clinical outcomes in subsequent clinical studies or real-world use of INGREZZA; 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, 2025. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law. 

 © 2026 Neurocrine Biosciences, Inc. All Rights Reserved. CAP-VBZ-US-0094   03/2026

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