Schering-Plough gets EU approval for opioid dependence drug

Schering-Plough has revealed it has received approval from the European Commission to market Suboxone, a new treatment for opioid dependence.

This makes it the first centrally-approved drug for the condition, which is often seen in heroin users who are mostly left untreated, the company states.

The European Commission’s approval was formed on the basis of a one-year clinical trial in opiate-dependent patients, in which Suboxone was compared against buprenorphine.

Schering-Plough’s new drug was found to show similar efficacy and safety to buprenorphine, although a higher percentage of Suboxone users demonstrated negative readings in thrice-weekly urine tests for opiates not used in the study.

Robert J Spiegel, chief medical officer and senior vice president of the Schering-Plough research institute, commented: “The European Commission’s approval of Suboxone represents an important advance in public health.”

He added that the drug was “expressly designed” to provide a treatment with the same efficacy and tolerability of buprenorphine, but with a lower potential for misuse.

Some 90 per cent of heroin that reaches the UK originates from Afghanistan or Burma, according to the BBC.