EU approves opioid misuse drug

Suboxone is intended for use in adults and adolescents 15 years of age and older who have agreed to be treated for addiction.

Suboxone is currently the only centrally-approved product for treatment of opioid dependence in the EU. The approval follows a positive opinion recommending approval that was granted in July by the European Medicines Agency.

Drug dependence is a worldwide public health problem of which opioid dependence, notably involving heroin, is a major component. In Europe, there are an estimated 1.1 million intravenous drug users (IVDUs), of whom more than 70% are untreated.

“There is a pressing need for improved opioid treatment medications with decreased potential for misuse in order to help further expand effective treatment into mainstream medical settings, and thereby improve patient access to treatment,” said professor John Strang, director of the National Addiction Centre in London.

Suboxone was developed as an alternative to the current treatment for opioid misuse, Subutex, as Suboxone has a lower potential for misuse.

Subutex is an established medical treatment for opioid dependence currently available in Europe, the US and more than 30 countries worldwide. Schering-Plough licenses marketing rights to Suboxone and Subutex in Europe, Canada and certain countries in the Middle East, Latin America and the Far East from Reckitt Benckiser.