Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today presented findings from a meta-analysis of three long-term studies evaluating INGREZZA® (valbenazine) capsules that demonstrated substantial and sustained improvements in tardive dyskinesia (TD) in adults with or without concomitant antipsychotic therapy. The data (Poster #4) were presented at 2023 Psych Congress Elevate in Las Vegas.
The analysis of the three studies (KINECT™ 3, KINECT™ 4, and J-KINECT™) demonstrated that treatment with once-daily INGREZZA (40 mg or 80 mg) resulted in substantial and sustained TD improvement through week 48 as measured by the Abnormal Involuntary Movement Scale (AIMS) total score, with no meaningful differences between study completers taking antipsychotics at baseline (AP+) and those who were not (AP-).
Upon withdrawal of INGREZZA, both subgroups experienced a return toward baseline severity of TD symptoms, demonstrating the potentially persistent nature of TD, even in patients no longer taking antipsychotic therapy. Researchers concluded that continuous treatment with INGREZZA to manage TD may be warranted irrespective if they were on concurrent antipsychotic therapy.
“TD may persist even after patients are no longer taking antipsychotic therapy,” said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. “These data from three long-term studies reinforce the continuing value of INGREZZA in TD management, regardless of antipsychotic status.”
Key results from the meta-analysis demonstrated the following:
- Mean baseline AIMS scores within each study ranged from 7.9 to 14.9 in the subgroup taking antipsychotics at baseline (AP+) and from 10.9 to 14.5 in the subgroup not taking antipsychotics at baseline (AP-)
- Mean changes from baseline in AIMS total scores within the combined group were similar between the AP+ and AP- subgroups and indicated substantial TD improvements with INGREZZA 40 mg and 80 mg at week 48 (AP+, -6.1; AP-, -6.5)
- Both AP+ and AP- subgroups within the combined group experienced a return toward baseline severity at week 52, four weeks after INGREZZA 40 mg or 80 mg withdrawal (AP+, -2.1; AP-, -1.4)
Additional presentations include:
- Global Improvements and Psychiatric Stability in Adults With Tardive Dyskinesia and Mood Disorder: Post Hoc Analyses of Two Long-Term Valbenazine Studies (Poster #3)
The full abstracts presented by Neurocrine Biosciences at 2023 Psych Congress Elevate are available on the meeting website and can be accessed by registering.
