New 48-Week Remission Data on Ingrezza for the Treatment of Tardive Dyskinesia

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Neurocrine Biosciences presented new data from the long-term, open-label KINECT 4 study demonstrating remission of tardive dyskinesia (TD) among most patients treated with once-daily valbenazine (Ingrezza) capsules, at the 2025 Psychiatry Update Conference in Chicago.¹

"These findings further establish Ingrezza as a highly effective long-term treatment option for individuals living with tardive dyskinesia, regardless of their underlying psychiatric condition, including schizophrenia, schizoaffective disorder, or mood disorder," said Eiry W. Roberts, MD, chief medical officer of Neurocrine Biosciences.

Investigators conducted a post-hoc analysis using data from 103 participants who reached the final week 48 visit in the KINECT 4 clinical trial and assessed a proposed threshold for remission of TD symptoms using the Abnormal Involuntary Movement Scale (AIMS). The threshold for remission was defined as an AIMS item score of ≤1 (rating of "none" or "minimal") in each of the 7 body regions. The percentage of participants who met the threshold for remission was analyzed by dose (40 mg and 80 mg) and by psychiatric diagnosis (schizophrenia or schizoaffective disorder, mood disorder). Most participants who received 48 weeks of once-daily Ingrezza reached the threshold for remission of TD while on treatment, regardless of underlying psychiatric diagnosis or dose. Approximately 59.2% (61/103) of participants who completed the study achieved remission, with 58.6% (17/29) of participants on the 40 mg dose and 59.5% (44/74) of participants on the 80 mg dose. Both 40 mg and 80 mg doses of Ingrezza showed significant improvements in AIMS total scores, with mean baseline scores of 12.4 (40 mg) and 15.1 (80 mg) decreasing to 2.1 and 2.5, respectively, at week 48. Remission rates were consistent across psychiatric diagnoses. Approximately 57.7% (41/71) of participants with schizophrenia or schizoaffective disorder achieved remission and 62.5% (20/32) of participants with mood disorders achieved remission.

"The significant improvements observed in AIMS score and the high remission rates highlight the efficacy of Ingrezza, at even the lowest dose,” said Roberts.

KINECT 4 is a phase 3, open-label study, in which 163 participants with moderate to severe TD and an underlying diagnosis of 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 4-week washout. Investigators initiated dosing 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. Participants were discontinued if the new dose was not tolerated. Consistent with previous studies, Ingrezza was generally well tolerated. After week 4, treatment emergent adverse events that occurred in more than 5% of all participants (combined dose groups) were urinary tract infection (8.5%) and headache (5.2%). Changes from baseline in psychiatric stability, vital signs, electrocardiogram parameters, and laboratory test values were generally small and not clinically significant.

Last month, Neurocrine shared top-line data from the phase 4 KINECT-PRO study, in which Ingrezza demonstrated clinically meaningful and sustained effects on the physical, social, and emotional impacts experienced by patients living with TD, regardless of TD severity or underlying psychiatric conditions. KINECT-PRO became the first study to show patient-reported impact of a vesicular monoamine transporter 2 inhibitor on TD using multiple clinically validated scales.²

References

1. Neurocrine Biosciences presents 48-week remission data on treatment of tardive dyskinesia with Ingrezza® (valbenazine) capsules. News release. March 20, 2025. https://www.prnewswire.com/news-releases/neurocrine-biosciences-presents-48-week-remission-data-on-treatment-of-tardive-dyskinesia-with-ingrezza-valbenazine-capsules-302406507.html

2. Kuntz L. Significant improvements in functionality and quality of life: new data on Ingrezza for tardive dyskinesia. Psychiatric Times. February 27, 2025. https://www.psychiatrictimes.com/view/significant-improvements-in-functionality-and-quality-of-life-new-data-on-ingrezza-for-tardive-dyskinesia