Short- and Long-term Effects of Once-Daily Valbenazine on Tardive Dyskinesia by Body Region (P4.079)

Objective: To explore the effects of once-daily valbenazine on tardive dyskinesia (TD) in different body regions using a shift analysis designed to assess clinically meaningful improvements. Background: Valbenazine (INGREZZA®), a novel highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is approved to treat TD in adults. Because the distribution and severity of TD can be heterogeneous, Abnormal Involuntary Movement Scale (AIMS) data from a Phase 3 trial (KINECT3, NCT02274558) were analyzed by body region. Design/Methods: KINECT3 included a double-blind, placebo-controlled period (Wk6), followed by a valbenazine extension period (Wk48) and washout (Wk52). For each of the 7 AIMS items (body regions) that constitute the total score, improvements (shifts) from a moderate/severe rating (score ≥3) at baseline to a mild/minimal/none rating (score ≤2) at Wk6, Wk48, and Wk52 were analyzed. Results: At Wk6, significantly more participants had an improvement (shift) with one or both doses of valbenazine versus placebo in the following regions (80mg, 40mg, placebo; * P Conclusions: For each body region, ≥50% of participants who had moderate/severe abnormal movements at baseline improved to mild/minimal/none movements after 6 weeks with valbenazine (80mg and/or 40mg), with sustained improvements during long-term treatment. Some participants continued to experience clinically meaningful shifts even after treatment withdrawal. Study Supported by: Supported by Neurocrine Biosciences, Inc. Disclosure: Dr. Comella has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Merz Pharmaceutical, Revance Therapeutic, Retrophin Therapeutic. She receives compensation/honoraria for services as a consultant or an advisory committee member: Acorda Therapeutics, Allergan, Inc;; Lundbeck Ltd.;Medtronic Inc.; Merz Pharmaceuticals;Acadia Pharmaceuticals; Jazz Pharmaceuticals, Neurocrine Biosciences Inc., Revance Therapeutic. She receives royalties from Cambridge, Wolters Kluwer. . Dr. Singer has nothing to disclose. Dr. Lessig has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Advisory board attendee for Neurocrine Biosciences, Inc. Dr. Burke has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Neurocrine Biosciences, Inc. Dr. Farahmand has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Neurocrine Biosciences, Inc. Dr. Hinton has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Neurocrine Biosciences, Inc. Dr. Liang has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Neurocrine Biosciences, Inc. Dr. Siegert has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Neurocrine Biosciences, Inc.