Long-term safety and efficacy data from the KINECT 3 Phase 3 extension study demonstrated that valbenazine (Ingrezza; Neurocrine Biosciences) maintained symptom improvement and was generally well-tolerated in patients with tardive dyskinesia. The findings were published in the Journal of Clinical Psychiatry.
Patients who completed the 6-week double-blind, placebo-controlled period of the KINECT 3 Phase 3 extension study were eligible to enter the 42-week extension period and subsequent 4-week washout period. The extension study included 198 patients receiving valbenazine for long-term treatment. Those who continued beyond the 6-week controlled study period maintained tardive dyskinesia improvement as measured by the Abnormal Involuntary Movement Scale and Clinical Global Impression of Change-TD through the 42-week double-blind extension period. Some return toward baseline severity was noted during the 4-week washout period.
With regard to safety, valbenazine-treated patients showed no apparent risk for suicidal ideation or behavior, nor did the drug appear to induce or worsen akathisia or parkinsonism. Generally, the authors noted, psychiatric status remained stable during the study.
“Long-term treatment with once-daily valbenazine at 80 or 40mg/d was generally well tolerated in participants with [tardive dyskinesia] regardless of concomitant psychiatric medication or underlying psychiatric diagnoses,” the authors concluded.
Ingrezza is available in 40mg and 80mg capsules.
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