Source - SMW
Indivior  said the US Food and Drug Administration's psychopharmacologic drugs advisory and drug safety and risk management advisory committees voted 18 to 1 to recommend approval of RBP-6000 for the treatment of opioid use disorder (OUD). 

RBP-6000 is an investigational once-monthly injectable buprenorphine formulation in the ATRIGEL delivery system for the treatment of adults with moderate-to-severe OUD, as part of a complete treatment plan to include counseling and psychosocial support.   Indivior chief executive  Shaun Thaxter said: 'The advisory committees' favourable recommendation of RBP-6000 moves us one step closer to potentially bringing this once-monthly injectable buprenorphine treatment option to patients struggling with opioid use disorder.

 'We are committed to pioneering new options for patients living with this chronic, yet treatable disease to help address the nation's growing opioid epidemic.'

The FDA will consider the advisory committees' non-binding recommendation in its review of the new drug application for RBP-6000 that was submitted by Indivior on 30 May. 

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of 30 Nov.




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