Neurocrine Biosciences presents new data highlighting functional and socio-emotional improvements with INGREZZA® (valbenazine) capsules in individuals with Tardive Dyskinesia and intellectual and developmental disabilities

Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced new clinician-reported data in patients with intellectual and developmental disabilities demonstrating meaningful and rapid improvements in tardive dyskinesia severity, as well as improvements in overall functional status, including physical and socio-emotional outcomes, with INGREZZA^® (valbenazine) capsules. The findings were presented at the American Academy of Developmental Medicine and Dentistry’s 24th Annual Education Conference in Dallas.

These data highlight the significant burden associated with tardive dyskinesia (TD) in individuals with intellectual and developmental disabilities, as well as the rapid clinician-reported improvements seen in TD movements following treatment with INGREZZA. Clinicians also observed functional gains across multiple areas of daily living, including social and emotional well-being, communication abilities and motor skills, such as hand coordination.

“People with intellectual and developmental disabilities are at increased risk for tardive dyskinesia due to long-term antipsychotic use, yet the condition often goes underdiagnosed and its impact underrecognized,” said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. “The clinician-reported improvements observed in this analysis complement patient-reported outcomes from the KINECT-PRO study, further highlighting the potential of INGREZZA to make a meaningful difference in areas that matter most to people living with tardive dyskinesia. This analysis, which is the first and only of its kind, also reflects our ongoing commitment to advancing studies that better represent and serve the diverse populations affected by the condition.”

This analysis was based on clinician‑reported data from patients who initiated INGREZZA between January and June 2024, completed at least two months of treatment and had at least one follow‑up visit, including a subgroup of 30 individuals with reported intellectual and developmental disabilities (mean age: 47.3 years; standard deviation: 14.6). The most common psychiatric comorbidities in this subgroup were schizophrenia (70%) and mood disorders (17%). Clinicians also reported that 70% of individuals had moderate or severe TD movement severity at baseline.

Nearly all individuals experienced reductions in TD symptoms, with 89% (25/28) demonstrating improvement within four weeks of treatment initiation. Clinicians reported substantial burden associated with TD at baseline, with functional status and independence negatively impacted in 90% of individuals in the study due to their TD symptoms. Following treatment with INGREZZA, clinicians reported improvement in overall functional status in 96% of study participants with impaired function, as well as broad improvements across key aspects of daily life.

Outcome	Baseline: % Patients Negatively Impacted	Posttreatment: % Patients Improved*
Overall functional status	90 %	96 %
Independence	90 %	83 %
Emotions	90 %	85 %
Socializing with family and friends	83 %	92 %
Dexterity	73 %	91 %
Speech	53 %	100 %
*Percentage improved among patients who were negatively impacted at baseline

A previous publication examined the use of INGREZZA in five adults with mild to severe intellectual and developmental disabilities and TD. Following treatment with INGREZZA, patients experienced reduced TD movements, accompanied by improvements in daily functioning, demeanor and social and caregiver interactions. The present analysis extends those findings, emphasizing the need to recognize the burden of TD beyond uncontrolled movements, including functional and socio-emotional outcomes that are especially meaningful for patients with intellectual and development disabilities, as well as their families and care partners.

Additional presentation at the American Academy of Developmental Medicine and Dentistry’s 24th Annual Education Conference included:

• Use and Misuse of Anticholinergics for Drug Induced Movement Disorders