An Open-Label, Long-Term Safety and Tolerability Study of RBP-7000 in the Treatment of Subjects With Schizophrenia

Trial Profile

An Open-Label, Long-Term Safety and Tolerability Study of RBP-7000 in the Treatment of Subjects With Schizophrenia

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2017

At a glance

  • Drugs Risperidone (Primary) ; Risperidone (Primary)
  • Indications Schizophrenia
  • Focus Adverse reactions; Registrational
  • Sponsors Indivior; Reckitt Benckiser
  • Most Recent Events

    • 12 Dec 2017 According to an Indivior media release,The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for RBP-7000, an investigational, once-monthly injectable risperidone in the ATRIGEL delivery system for the treatment of schizophrenia.The FDA has set a PDUFA (Prescription Drug User Fee Act) target action date of July 28, 2018.
    • 28 Sep 2017 According to an Indivior media release, based on the data from this and other trial (see profile 243591), the company has submitted a New Drug Application (NDA) to the U.S. FDA to seek marketing approval for RBP-7000 in the ATRIGEL delivery system for the treatment of schizophrenia.
    • 12 Jan 2017 Status changed from active, no longer recruiting to completed.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top