Indivior PLC (LON: INDV) today announced top-line results from its phase 3 clinical trial of RBP-7000, 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.
“With these positive phase 3 data in hand, we are moving forward expeditiously to complete the open-label long-term assessment of the safety and tolerability of RBP-7000,” said Christian Heidbreder, Ph.D., Chief Scientific Officer of Indivior. “We understand there is a great unmet need among patients living with this chronic disease, and we hope to bring a new, long-acting treatment option to those individuals and the physicians who treat them.”
Based on the success of the open-label phase of the trial, Indivior expects to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration for potential approval in 2017.
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, p=0.0004 vs. placebo; and -16.4 points for RBP-7000, 120 mg, p<0.0001 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.