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Psych Congress  

KINECT 3: A Phase 3 Study of Valbenazine (NBI-98854) for the Treatment of Tardive Dyskinesia

Stephen Marder, MD; Robert Hauser, MD; Scott Siegert, PharmD; Clinton Wright, PharmD; Christopher O'Brien, MD
Neurocrine Biosciences, Inc.

This poster was presented at the 29th Annual U.S. Psychiatric & Mental Health Congress, held October 21-24, 2016, in San Antonio, Texas.

Tardive dyskinesia (TD) is a persistent movement disorder associated with chronic exposure to dopamine receptor blocking agents (e.g., antipsychotics) for which no FDA-approved treatment is indicated. Valbenazine is a novel and highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor, currently under evaluation for the treatment of TD. KINECT 3 (NCT02274558), a 6-week, double-blind, placebo-controlled study, was conducted in subjects with moderate-to-severe TD and underlying schizophrenia, schizoaffective disorder, or mood disorder. Subjects were randomized (1:1:1) to once-daily placebo, valbenazine 40 mg, or valbenazine 80 mg. The primary outcome was change from baseline (CFB) at Week 6 in the Abnormal Involuntary Movement Scale (AIMS) score, with efficacy defined as a significant difference between valbenazine 80 mg and placebo. Safety assessments included adverse events (AEs), laboratory tests, electrocardiograms, and psychiatric assessments. At Week 6 in the intent-to-treat population (N=225), AIMS score CFB was significantly greater with valbenazine 80 mg versus placebo: -3.2 versus -0.1; P<0.0001. AIMS CFB was also greater with valbenazine 40 mg than placebo: -1.9 versus -0.1; P=0.0021 (full description of supportive analyses to be presented). AE rates were generally similar across treatment groups; 6% of all subjects discontinued due to treatment-emergent AEs. Mean changes in additional safety outcomes were similar between valbenazine and placebo. In KINECT 3, once-daily valbenazine significantly reduced TD symptoms in subjects with schizophrenia, schizoaffective disorder, or mood disorder. Valbenazine was also well tolerated, with no apparent effects on laboratory parameters, cardiac function, or psychiatric status.    

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