Investigational Drug Shows Promise as Schizophrenia Treatment

RP5063, a novel dopamine serotonin stabilizer, was associated with symptom improvement in adults with acute exacerbation of schizophrenia or schizoaffective disorder, researchers found in a randomized clinical trial.

The 28-day, double-blind study had 234 participants, who took either aripiprazole, 15, 30, or 50 mg of RP5063, or placebo once a day.
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The total score on the Positive and Negative Syndrome Scale (PANSS) for the RP5063 groups decreased by an average of 20.23 (15 mg), 15.42 (30 mg), and 19.21 (50 mg), compared with an 11.41-point decrease for the placebo group.  The difference was statistically significant for the 15 mg and 50 mg groups.

All-cause discontinuation rates for the RP5063 groups were 14% (15 mg), 25% (30 mg), and 12% (50 mg), compared with 35% for the aripiprazole group and 26% for the placebo group.

The most common side effects in the RP5063 groups were insomnia and agitation. Those groups saw decreases in blood glucose, lipid profiles, and prolactin levels, and there were no significant changes in body weight, electrocardiogram, or incidence of orthostatic hypotension, according to the authors of the study.

“RP5063 is an efficacious and well-tolerated treatment for acute exacerbation of schizophrenia or schizoaffective disorder,” they wrote.

Reviva Pharmaceuticals, which describes RP5063 as its “lead development product,” conducted the study. Results are published in Schizophrenia Research. 

—Terri Airov

References

Cantillon M, Prakash A, Alexander A, et al. Dopamine serotonin stabilizer RP5063: A randomized, double-blind, placebo-controlled multicenter trial of safety and efficacy in exacerbation of schizophrenia or schizoaffective disorder. Schizophrenia Research. 2017 February 16;[Epub ahead of print].