Bioequivalence study comparing Zubsolv with Suboxone sublingual tablets

Trial Profile

Bioequivalence study comparing Zubsolv with Suboxone sublingual tablets

Completed
Phase of Trial: Phase I

Latest Information Update: 15 Sep 2017

At a glance

  • Drugs Buprenorphine/naloxone (Primary)
  • Indications Opioid abuse
  • Focus Pharmacokinetics; Registrational
  • Most Recent Events

    • 15 Sep 2017 According to an Orexo media release, based on the data from this and some other studies The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for Zubsolv (buprenorphine and naloxone sublingual tablet) for use in the treatment of opioid dependence. The European Commission will now review the CHMP opinion and a final decision is expected in Q4, 2017.
    • 18 Oct 2016 New trial record
    • 04 Oct 2016 Results published in an Orexo media release.
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