RBP-7000

 

Overview

RBP‑7000 is an investigational once-monthly injectable risperidone product under study for the treatment of schizophrenia. It is being developed by Indivior PLC.

RBP‑7000 has not been approved by the FDA for marketing in the U.S. for any indication.

According to Phase 3 and HEOR data presented by Indivior on December 9, 2016, RBP‑7000 could provide the following benefits:

  • Once-a-month dosing
  • Rapid onset of action
  • No loading dose with initiation of treatment
  • No supplemental dosing during treatment

RBP‑7000 is an investigational new drug and has not been approved by the FDA for marketing in the U.S. for any indication.

Approximately 2.4 million adult Americans suffer from schizophrenia. Long-acting injectables (LAI) have been shown to increase adherence and lower rates of relapse and psychiatric hospitalizations compared with oral therapy.  LAI sales to treat schizophrenia were approximately $2.4 billion in 2016.

RBP-7000 is an investigational new drug currently under review by the FDA. It has not been approved for marketing in the U.S. for any indication.

Indivior has submitted a New Drug Application (NDA) for RBP‑7000 to the U.S. Food and Drug Administration (FDA). This NDA has been accepted for review by the FDA, and the FDA has set a PDUFA (Prescription Drug User Fee Act) target action date of July 28, 2018.

In September 2017, DURECT assigned certain of its U.S. patent rights to Indivior. For a description of the associated terms, please see Collaborations.

There are risks and uncertainties associated with our business. Please see our most recent SEC filings (10-K or 10-Q) for a complete description of these risks and uncertainties, which are incorporated herein by reference.