SCHERING'S SUBOXONE APPROVED IN EUROPE FOR OPIOID DEPENDENCE

Schering-Plough announced that the European Commission has granted marketing approval to Suboxone (buprenorphine hydrochloride/naloxone hydrochloride) Sublingual Tablets for the substitution treatment of opioid dependence, within a framework of medical, social and psychological treatment. The intention of adding the naloxone component is to deter intravenous misuse. Suboxone is intended for use in adults and adolescents 15 and older who have agreed to be treated for addiction.

Suboxone currently is the only centrally approved product for treatment of opioid dependence in the European Union. The approval results in marketing authorization with unified labeling that is valid in the current 25 EU member states as well as in Iceland and Norway. The approval follows a positive opinion recommending approval by the Committee for Medicinal Products for Human Use.

The European Commission's approval is based primarily on results of a one-year clinical trial in opiate-dependent patients, comprising a four-week randomized double-blind comparison of Suboxone, buprenorphine monotherapy and placebo tablets followed by a 48-week safety study of Suboxone. The primary study comparison was to assess the efficacy of Suboxone and buprenorphine individually versus placebo. In the study, Suboxone demonstrated similar efficacy and safety to buprenorphine.