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.
Schizophrenia is a chronic, severe and disabling brain disorder that affects an estimated 26 million people worldwide. Treatment is aimed at reducing or eliminating the symptoms of the disease and often includes antipsychotic medications and various psychosocial treatments.