European regulators have granted
marketing approval approval for Suboxone, its treatment for opioid dependence.
The drug, a tablet that dissolves under the tongue, eliminates opioid cravings and withdrawal symptoms. The active ingredient buprenorphine alone can be abused intravenously to achieve a high, but with the addition of another drug known as naloxone in Suboxone, abusers are deterred from crushing and injecting the oral treatment. Naloxone quickly causes significant withdrawal symptoms when injected intravenously, according to a company spokesman.
Suboxone is already approved for use in the U.S., where it's marketed by
, the drug's developer. The European Union approval follows a positive opinion and recommendation for approval in July from a European Medicines Agency committee that reviewed the drug.
"Opioid dependence is a chronic relapsing medical condition that requires long-term treatment and patient support," said Dr. Robert J. Spiegel, Schering-Plough's chief medical officer. "Suboxone was expressly designed to provide the proven efficacy and tolerability of Subutex (buprenorphine) with a lower potential for misuse."
Schering-Plough's shares dipped 3 cents to $22.07 in recent trading Friday.