Neurocrine Biosciences announced results from its Phase 2a study of NBI-98854 for the treatment of tardive dyskinesia. This open-label trial was designed to assess efficacy, safety and tolerability of NBI-98854 in up to ten schizophrenia patients who have moderate to severe tardive dyskinesia over a twelve day period. The efficacy of the drug was measured using the Abnormal Involuntary Movement Scale (AIMS). Baseline AIMS score was 14.3 (AIMS total items 1–7, possible total score of 28). After twelve days of dosing in six subjects, the mean AIMS score decreased to 8.4, a reduction of 41.3%. After the seven-day washout period following dosing, most patients’ AIMS score returned to their baseline levels.
NBI-98854 is a vesicular monoamine transporter 2 inhibitor (VMAT2), a protein concentrated in the human brain that is primarily responsible for re-packaging and transporting monoamines (dopamine, norepinephrine, serotonin, and histamine) among nerve cells. It modulates dopamine release during nerve communication, while at the same time having minimal impact on the other monoamines thereby reducing the likelihood of “off target” side effects. NBI-98854 is designed to provide low, sustained, plasma and brain concentrations of active drug to minimize side effects associated with excessive dopamine depletion.
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