RBP 7000 (risperidone subcutaneous) meets endpoints in Phase III trial for Schizophrenia- Indivior

Indivior has announced top-line results from its Phase III clinical trial of RBP 7000 (risperidone subcutaneous), an investigational drug in development for the treatment of Schizophrenia. In this pivotal study, both doses of RBP 7000 tested, 90 mg and 120 mg administered once-monthly, met the primary endpoint with statistically and clinically significant reductions in the symptoms of acute schizophrenia over an 8-week treatment period.

Symptom reduction was measured using the change from baseline to end of treatment in the total Positive and Negative Syndrome Scale (PANSS) scores. RBP 7000 also met the key secondary endpoint with statistically significant improvements in the Clinical Global Impression-Severity of Illness (CGI-S) scale compared with placebo over the 8-week treatment period using change from baseline to end of treatment. During the 8-week, double-blind treatment period, patients treated once-monthly with either 90 mg or 120 mg of RBP 7000 demonstrated statistically and clinically significant mean reductions from baseline in PANSS total scores (-9.2 points for placebo; -15.4 points for RBP 7000, 90 mg,; and -16.4 points for RBP 7000, 120 mg vs. placebo).

In addition to meeting the pre-specified primary efficacy endpoint of PANSS total score reduction, the study also met the pre-specified key secondary endpoint of improvement on the CGI-S scale for each RBP 7000 group vs. placebo at Week 8 (p=0.0002 vs. placebo for RBP 7000, 90 mg; and p<0.0001 vs. placebo for rbp 7000 120 mg. rbp 7000 was generally well tolerated in the study and the observed safety profile of rbp 7000 was similar to that reported with oral risperidone. based on the success of the open-label phase of the trial indivior expects to submit a new drug application to the fda for potential approval in 2017.>