Bioequivalence study comparing Zubsolv with Suboxone sublingual tablets
Phase of Trial: Phase I
Latest Information Update: 20 Nov 2017
At a glance
- Drugs Buprenorphine/naloxone (Primary)
- Indications Opioid abuse
- Focus Pharmacokinetics; Registrational
- 20 Nov 2017 According to an Orexo media release, based on the data from this and other studies, the European Medicines Agency (EMA) has granted a Marketing Authorization (MA) for Zubsolv (buprenorphine and naloxone), a novel rapidly-disintegrating treatment option for opioid dependence.
- 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