Posted by Michael Wonder on 03 Oct 2017
Indivior submits new drug application to U.S. FDA for RBP-7000 risperidone monthly depot for treatment of schizophrenia
2 October 2017 - Enters into agreement with Durect to expand patent estate for RBP-7000.
Indivior today announced that its U.S. subsidiary, Indivior Inc. successfully submitted a new drug application to the U.S. FDA on 28 September 2017 to seek marketing approval for RBP-7000, Indivior’s investigational, once-monthly injectable risperidone in the Atrigel delivery system for the treatment of schizophrenia.
This submission includes the results from the pivotal Phase 3 study assessing the efficacy and safety of RBP-7000 and an open-label, long-term safety study. In the pivotal randomised, double-blind, placebo-controlled study (RB-US-09-0010), RBP-7000 demonstrated statistically clinical improvement compared to placebo based on changes in mean Positive and Negative Syndrome Scale (PANSS) total and Clinical Global Impression-Severity of Illness scores at 8 weeks.
