title: Efficacy, Safety, and Tolerability of RBP-7000 Once-Monthly Risperidone for the Treatment of Acute Schizophrenia: An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study.
abstract: RBP-7000 is a sustained-release formulation of risperidone for the treatment of schizophrenia, designed to be administered by once-monthly subcutaneous injection using the ATRIGEL delivery system. This study assessed the efficacy, safety, and tolerability of RBP-7000 compared with placebo in subjects with acute exacerbation of schizophrenia. Inpatients were randomly assigned to 8 weeks of double-blind treatment with subcutaneous 90 or 120 mg of RBP-7000 or placebo. Efficacy was evaluated using a mixed-model repeated-measures analysis of the change from baseline (the last nonmissing value before the first dose of RBP-7000 or placebo on day 1) to end of the study in Positive and Negative Syndrome Scale (PANSS) total score (primary efficacy measure) and Clinical Global Impression-Severity score (secondary efficacy measure). The least-squares means from the repeated-measures analysis for the change from baseline in the PANSS total scores for placebo was -9.219 (SE, 1.2162). RBP-7000 produced statistically and clinically significant differences in mean reductions from baseline in PANSS total scores (90-mg RBP-7000 compared with placebo, -6.148 [-9.982 to -2.314], P = 0.0004; 120-mg RBP-7000 compared with placebo, -7.237 [-11.045 to -3.429], P < 0.0001) and significantly improved Clinical Global Impression-Severity scores (90-mg RBP-7000 compared with placebo, -0.350 [-0.557 to -0.143], P = 0.0002; 120-mg RBP-7000 compared with placebo, -0.396 [-0.602 to -0.190], P < 0.0001). Both RBP-7000 dosages were generally well tolerated. The most frequently reported treatment-emergent adverse events in RBP-7000 groups compared with placebo were somnolence, weight gain, and akathisia. The overall incidence of extrapyramidal syndrome-related effects was low and similar across groups. RBP-7000 may provide a new, long-acting alternative treatment for use in adults with acute schizophrenia.
authors: From the *Global Research & Development, Indivior, Inc, Richmond, VA; †Schizophrenia Clinical and Research Program/Chester M. Pierce, MD Division of Global Psychiatry, Massachusetts General Hospital; ‡Department of Psychiatry, Harvard School of Public Health, Harvard Medical School; §Division of Clinical Research/Department of Psychiatry/Clinical Trials Network and Institute, Massachusetts General Hospital; and ∥Department of Psychiatry, Harvard Medical School, Boston, MA.
authors: Azmi F
authors: AF
authors: Nasser
authors: David C
authors: DC
authors: Henderson
authors: Maurizio
authors: M
authors: Fava
authors: Paul J
authors: PJ
authors: Fudala
authors: Philip
authors: P
authors: Twumasi-Ankrah
authors: Alex
authors: A
authors: Kouassi
authors: Christian
authors: C
authors: Heidbreder
mesh_terms: D017109:Akathisia, Drug-Induced / Q000175:diagnosis; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001007:Anxiety / Q000139:chemically induced / Q000175:diagnosis; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D018967:Risperidone / Q000008:administration & dosage* / Q000009:adverse effects; D012559:Schizophrenia / Q000175:diagnosis* / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D018967:Risperidone