Healthcare Industry News:  sublingual tablet 

Biopharmaceuticals Regulatory

 News Release - July 28, 2006

European Union's CHMP Adopts Positive Opinion for SUBOXONE(R) (Buprenorphine/Naloxone) for Treatment of Opioid Dependence

KENILWORTH, N.J., July 28 (HSMN NewsFeed) -- Schering-Plough Corporation (NYSE: SGP ) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has granted a positive opinion recommending 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 of SUBOXONE 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 (EU) 25 member states as well as in Iceland and Norway.

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 percent are untreated. In some instances, IVDUs share syringes and needles, a practice that can lead to the transmission of serious blood-borne diseases such as human immunodeficiency virus (HIV), hepatitis B and hepatitis C.

"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 Clinical Studies

The CHMP recommendation of SUBOXONE is based primarily on results of a one-year clinical trial in opiate-dependent patients, comprising a 4-week randomised double-blind comparison of SUBOXONE, buprenorphine monotherapy and placebo tablets followed by a 48-week safety study of SUBOXONE. The primary study comparison was to assess the efficacy of SUBOXONE and buprenorphine individually versus placebo. 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 (p<0.0001) and buprenorphine versus placebo (p<0.0001). 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 is committed to conducting additional clinical studies in patients who switch treatments from sublingual buprenorphine to SUBOXONE, as well as in patients who initiate treatment with SUBOXONE.

Sublingual buprenorphine, marketed as SUBUTEX® (buprenorphine hydrochloride) C-III sublingual tablets, is an established substitution treatment for opiate dependence currently available in Europe, the United States and more than 30 countries worldwide.


SUBOXONE and SUBUTEX were developed and are marketed in the United States and certain other countries by Reckitt Benckiser Pharmaceuticals Inc. Schering-Plough licenses international marketing rights to SUBOXONE and SUBUTEX (excluding the United States, Japan, Taiwan, Korea, Australia and New Zealand) from Reckitt Benckiser. Reckitt Benckiser Pharmaceuticals Inc. is a wholly owned subsidiary of Reckitt Benckiser PLC, a publicly traded UK firm.

Reckitt Benckiser Pharmaceuticals U.S. Statement of Fair Balance

Intravenous use of buprenorphine, usually in combination with benzodiazepines or other CNS depressants has been associated with significant respiratory depression and death. SUBOXONE and SUBUTEX have potential for abuse and produces dependence of the opioid type with a milder withdrawal syndrome than full agonists. Cytolytic hepatitis and hepatitis with jaundice have been observed in the addicted population receiving buprenorphine. There are no adequate and well-controlled studies of SUBOXONE or SUBUTEX (a pregnancy category C medication) in pregnancy. Due caution should be exercised when driving cars or operating machinery. The most commonly reported adverse events with SUBOXONE have included headache (36%, placebo 22%), withdrawal syndrome (25%, placebo 37%), pain (22%, placebo 19%), nausea (15%, placebo 11%), insomnia (14%, placebo 16%), sweating (14%, placebo 10%). See full prescribing information for complete information.

About Schering-Plough

Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 32,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is

SCHERING-PLOUGH DISCLOSURE NOTICE: This press release contains certain "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including statements relating to the potential regulatory approval and market for SUBOXONE. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward- looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition and the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Item 1A. Risk Factors in the Company's second quarter 2006 10-Q.

SUBOXONE and SUBUTEX are registered trademarks of Reckitt Benckiser Pharmaceuticals Inc. and are used under license by Schering Corporation.

Source: Schering-Plough

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