Schering-Plough Corporation (NYSE: SGP) today announced that the European Commission has granted marketing approval to SUBOXONE(R) (buprenorphine
hydrochloride/naloxone hydrochloride) Sublingual Tablets for the
substitution treatment of opioid dependence, within a framework of medical,
social and psychological treatment. The intention of adding the naloxone
component 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.
SUBOXONE currently is the only centrally-approved product for treatment
of opioid dependence in the European Union (EU). The approval results in
Marketing Authorization with unified labeling that is valid in the current
25 EU member states as well as in Iceland and Norway. The approval follows
a positive opinion recommending approval that was granted on July 27 by the
Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMEA).
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.
"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, M.D., Director of
the National Addiction Centre, London, U.K. "With the approval of SUBOXONE,
the European medical and patient communities now have another safe and
effective option for managing opioid dependence," he said.
"The European Commission's approval of SUBOXONE represents an important
advance in public health," said Robert J. Spiegel, M.D., chief medical
officer and senior vice president, Schering-Plough Research Institute.
"Opioid dependence is a chronic relapsing medical condition that requires
long-term treatment and patient support. SUBOXONE was expressly designed to
provide the proven efficacy and tolerability of SUBUTEX (buprenorphine)
with a lower potential for misuse."
SUBUTEX(R) (buprenorphine hydrochloride) Sublingual Tablets is an
established medical treatment for opioid dependence currently available in
Europe, the United States and more than 30 countries worldwide.
Suboxone Clinical Studies
The European Commission's approval of SUBOXONE is based primarily on
results of a one-year clinical trial in opiate-dependent patients,
comprising a 4-week randomized 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
higher percentage of thrice-weekly urine samples testing negative for
non-study opiates for both SUBOXONE versus placebo and buprenorphine versus
placebo. 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 and 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.
About SUBOXONE and SUBUTEX
SUBOXONE and SUBUTEX were developed by Reckitt Benckiser Healthcare
Ltd. and are marketed in the United States by Reckitt Benckiser
Pharmaceuticals Inc. 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. 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.What are Opioids?
For more information on what opioids are, and opioid-induced constipation (OIC), please see:
All About Opioids and Opioid-Induced Constipation (OIC)
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.
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 market for SUBOXONE and the Company's commitment to conducting
additional future clinical studies 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
Healthcare (UK) Limited and are used under license by Schering Corporation.
Schering-Plough Corporation
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