Neurocrine Biosciences (NASDAQ: NBIX) announced the publication of results from its KINECT-PRO Phase 4 open-label study, showing that once-daily Ingrezza (valbenazine) capsules produced improvements in patient-reported quality of life and daily functioning among people with tardive dyskinesia (TD). The findings were published in CNS Spectrums.

The study enrolled 59 patients who received Ingrezza at doses of 40 mg, 60 mg, or 80 mg once daily for up to 24 weeks. Fifty-two patients completed the Week 24 visit, with 45 included in efficacy analyses. At baseline, approximately 41% of patients had mild TD movement severity, while 59% had moderate or severe TD.

Mean improvements in TD impact, as measured by the Tardive Dyskinesia Impact Scale (TDIS), and movement severity, as measured by the Abnormal Involuntary Movement Scale (AIMS), exceeded established thresholds for clinically meaningful change at Week 24. The overall patient population showed a mean change from baseline of -8.0 on the TDIS and -6.8 on the AIMS. Patients with mild TD at baseline showed mean changes of -6.8 on the TDIS and -5.6 on the AIMS.

Approximately 58% of patients met the threshold for TD symptomatic remission at Week 24, defined as a movement severity score of zero or one in each of seven body regions assessed by AIMS. Improvements were observed regardless of underlying psychiatric diagnosis or baseline movement severity.

"Quality of life and day-to-day functioning are important considerations when evaluating the impact of tardive dyskinesia and treatment goals," said Christoph U. Correll, M.D., professor of psychiatry at The Zucker Hillside Hospital and primary author of the manuscript. "These findings showed improvements with Ingrezza in both clinician-rated movement severity and patient-reported daily impact."

Safety and tolerability results were consistent with Ingrezza's known profile, with no new concerns identified. Ingrezza is approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia and chorea associated with Huntington's disease.