Schering-Plough Corp. received recommendation for approval of Suboxone from the Committee for Medicinal Products for Human Use (CHMP) of the EMEA. Suboxone sublingual tablets are for the substitution treatment of opioid dependence, within a framework of medical, social and psychological treatment.
Substitution treatment for opioid dependence is when opiate misuse is replaced with an oral opioid medication, such as buprenorphine or methadone, to deter intravenous misuse. Suboxone is intended for use in adults and adolescents 15 years of age and older who have agreed to be treated for addiction.
The CHMP recommendation will serve as the basis for a European Commission approval, which would result in Marketing Authorization with unified labeling valid in the 25 EU member states as well as in Iceland and Norway.