Posted by Michael Wonder on 01 Aug 2017
Indivior RBP-6000 NDA acceptance with priority review designation
31 July 2017 - FDA sets a PDUFA target action date of 30 November 2017.
Indivior today announces that the U.S. FDA has accepted with a priority review designation the new drug application for RBP-6000, an investigational once-monthly injectable buprenorphine in the Atrigel delivery system for the treatment of adults with moderate-to-severe opioid use disorder as part of a complete treatment plan to include counselling and psychosocial support.
The application, which was submitted on 30 May 2017, is based on data from the pivotal Phase 3 study (RBP-US-13-0001) assessing the efficacy and safety of RBP-6000.
