Abstract
To evaluate the efficacy and safety of Risperidone ISM® against placebo in patients with acute exacerbation of schizophrenia. A multicenter, randomized, double-blind, placebo-controlled study was conducted between June 2017 and December 2018 (NCT03160521). Eligible patients received once-monthly intramuscular injections of Risperidone ISM® (75 or 100 mg) or placebo for 12 weeks. The primary efficacy outcome was change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 12. The key secondary efficacy outcome was change from baseline in Clinical Global Impressions-Severity of Illness scale (CGI-S) score. Altogether, 438 patients were randomized (1:1:1) and 390 included in the modified ITT efficacy set. The PANSS total score (mean difference, 95% CI) improved significantly from baseline to day 85 with Risperidone ISM® 75 and 100 mg, with placebo-adjusted differences of −13.0 (95% CI, −17.3 to −8.8); (p < 0.0001), and −13.3 (−17.6 to −8.9); (p < 0.0001), respectively. Significantly improved mean changes were also obtained for CGI-S score from baseline to day 85 for both doses of Risperidone ISM® compared with placebo −0.7 (−1.0 to −0.5); p < 0.0001, for both doses. The statistically significant improvement for both efficacy outcomes were observed as early as 8 days after first injection. The most frequently reported treatment-emergent adverse events were increased blood prolactin (7.8%), headache (7.3%), hyperprolactinemia (5%), and weight increase (4.8%). Neither new nor unexpected relevant safety information was recorded. Risperidone ISM® provided rapid and progressive reduction of symptoms in patients with acutely exacerbated schizophrenia without need of oral risperidone supplementation or loading doses. Both doses were safe and well tolerated.
Highlights
Schizophrenia remains one of the most severe mental disorders[1]
The data obtained in the present study demonstrate the efficacy, safety, and tolerability of Risperidone ISM® in the monthly treatment of the acute schizophrenia
Superiority of active treatment versus placebo was shown for the primary efficacy outcome, with a statistically significant advantage of both Risperidone ISM® 75 mg and 100 mg to placebo on Positive and Negative Syndrome Scale (PANSS) total score mean change from baseline to Day 85 in the modified intent-to-treat (mITT) population
Summary
Schizophrenia remains one of the most severe mental disorders[1]. The suboptimal adherence to prescribed oral antipsychotic medication regimens is prevalent in patients with schizophrenia and has been associated with relapse and worsening of long-term functional and mental health outcomes[2,3,4]. Long-acting formulations of antipsychotic medications (LAIs), developed to promote treatment adherence, have helped to improve adherence and efficacy[5,6,7,8]. Laboratorios Farmacéuticos ROVI, S.A., has developed a new injectable formulation of risperidone using the ISM® technology. This technology is based on an in situ forming solid polymeric matrix system that contains risperidone. The suspension obtained after reconstitution produces an early, rapid, and sustained release of risperidone by 2 h after its administration and for 1 month[11]
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