Schering-Plough Corporation (NYSE: SGP)’s SUBOXONE® (buprenorphine hydrochloride/naloxone hydrochloride) Sublingual Tablets for the substitution treatment of opioid dependence, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA), thereby recommending the product for approval in the EU.
Later, an approval will result to a Marketing Authorization with unified labeling valid in the current European Union (EU) 25 member states as well as in Iceland and Norway.
Drug dependence is a worldwide public health problem. Its major component is opioid dependence, notably involving heroin. In Europe alone, there are an estimated 1.1 million intravenous drug users (IVDUs), of whom more than 70 percent are untreated.
The normal approach in the treatment of opoid dependence is substitution where in opiate misuse is replaced with an oral opioid medication such as buprenorphine or methadone.
In SUBOXONE® (buprenorphine hydrochloride/naloxone hydrochloride), the naloxone component is intended to deter intravenous misuse.
"The CHMP recommendation of SUBOXONE is welcome news for the patient and medical communities in Europe that manage opioid dependence," stated Marc Auriacombe, M.D., Professor of Psychiatry and Addiction Medicine, University Victor Segalen Bordeaux 2, Bordeaux, France.
"Opiate dependence is a disease that can be treated medically in combination with psychosocial support. The addition of a new safe and effective buprenorphine sublingual formulation that was expressly designed to reduce the potential for misuse represents an important advance, both medically and socially."
SUBOXONE® (buprenorphine hydrochloride/naloxone hydrochloride) is intended for the use of adults and adolescents, age 15 and older who have agreed to be treated for addiction.
More details from the Schering-Plough press release.
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