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news.Schering-Plough has announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion recommending approval of Suboxone in opioid dependence.
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The Committee for Medicinal Products for Human Use (CHMP)’s recommendation is for the approval of Suboxone (buprenorphine hydrochloride/naloxone hydrochloride) sublingual tablets for the substitution treatment of opioid dependence, within a framework of medical, social and psychological treatment.
Substitution is the treatment approach for opioid dependence in which opiate misuse is replaced with an oral opioid medication such as buprenorphine or methadone. The intention of the naloxone component of Suboxone is 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 current European Union 25 member states, as well as in Iceland and Norway.
The recommendation 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.
In the study, Suboxone demonstrated similar efficacy and safety to buprenorphine, with a significantly higher percentage of thrice-weekly urine samples testing negative for non-study opiates for both Suboxone versus placebo and buprenorphine versus placebo. The reported adverse events during the study for Suboxone were similar to those seen with buprenorphine monotherapy and were those generally seen with other opioid-agonist treatments (e.g., headache, withdrawal syndrome, insomnia).
Schering-Plough, which licensed marketing rights to Suboxone from Reckitt Benckiser Pharmaceuticals for certain worldwide territories, plans to conduct additional clinical studies in patients who switch treatments from sublingual buprenorphine to Suboxone, as well as in patients who initiate treatment with Suboxone.