Neurocrine Biosciences, Inc. announced the presentation of new data from a clinician survey highlighting the functional impact experienced by patients with mild tardive dyskinesia (TD) severity and the impact of treatment with INGREZZA (valbenazine) capsules in a real-world setting. In a subgroup analysis, nearly all patients with clinician-reported mild TD treated with INGREZZA experienced fewer uncontrolled movements, with most demonstrating symptom improvement within four weeks. Patients also showed widespread improvements in functional status, independence, ability to perform daily activities and ability to work.

The analysis was based on a previously conducted clinician survey of patient chart data and clinician recall evaluating TD symptoms, functional impairment and improvement following treatment with INGREZZA. The survey included adult patients with TD who initiated INGREZZA between January 1, 2024 and June 30, 2024, completed at least two months of treatment and had at least one follow-up visit. In total, 128 clinicians caring for 315 patients with TD on INGREZZA reported data.

This analysis focused on a subgroup of patients (n=90) with mild movement severity as rated by clinicians using global severity categories aligned with the Abnormal Involuntary Movement Scale. Prior to treatment, clinicians reported that mild TD movements impacted functional status in 90% of patients and independence in 84% of patients, with commonly affected areas including emotional (88%), social (86%), speech (61%), dexterity (60%) and eating (56%) functions. Following the initiation of INGREZZA, nearly all patients (96%) with mild TD experienced clinician-reported improvements in uncontrolled movements.

Of those patients, 86% improved in four weeks or less. Beyond improvements in uncontrolled movements, clinicians observed meaningful functional improvements across a range of daily life domains among patients with mild TD: For patients with impacted functional status (n=81), almost all (96%) had improvement in overall functional status. Across all functional items, clinicians reported improvement in more than 90% of impacted patients, including those with impacted speech (n=55), dexterity (n=54), social status (n=77), emotional status (n=79) and activities of daily living, such as eating (n=50) and self-care (n=44).

Among all patients, 83% (n=75/90) achieved improvement in independence with treatment. Among patients who were employed or attending school, 70% (n=21/30) experienced improved willingness or ability to work or attend school after initiating treatment. Findings from this survey and subpopulation analysis support the American Psychiatric Association clinical guidelines, which state that treatment with a vesicular monoamine transporter 2 inhibitor can be considered for patients with mild TD based on associated impairment or patient preference.

This research adds to the growing body of evidence demonstrating the benefits of INGREZZA in patients with TD, including those with mild movements. In clinical studies, including the Phase 4 KINECT-PRO study, INGREZZA has been shown to improve TD severity and patients have reported reductions in the physical, social and emotional burden of the condition. Together, these real-world and clinical data highlight the potential of INGREZZA to improve movements and associated functional outcomes in patients with TD, including those with mild involuntary movements prior to treatment.

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. 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. 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.