(N)SUBOXONE(TM) approved by Health Canada and available as new, effective
and safe treatment option for patients with opioid drug dependence
KIRKLAND, QC, Dec. 11 /CNW/ - Schering-Plough Canada Inc. announced today
that for the first time in more than 30 years, Canadians who are dependent on
opioids, such as heroin and opioid-based prescription pain medications
including hydromorphone and oxycodone, have a new, effective and safe
treatment option to combat their disease. (N)SUBOXONE(TM)
(buprenorphine/naloxone) was recently approved by Health Canada, and is now
available for substitution treatment in opioid drug dependence in adults.
SUBOXONE, a tablet that dissolves under the tongue, suppresses the symptoms of
opioid withdrawal and reduces the cravings for opioid drugs.(i)
"Most of the approximately 125,000 illicit drug users in Canada are
opioid dependent(ii), and three-quarters of these people are not in treatment
for their disease.(iii) We now have a new treatment option that will help our
patients manage their symptoms." said Dr. David Marsh, Physician Leader of
Addiction Medicine with Vancouver Coastal Health and Providence Health Care,
Clinical Associate Professor at the University of British Columbia, and
Past-President of the Canadian Society of Addiction Medicine. "Additionally,
from a safety perspective, when treating with SUBOXONE, there is lower
potential for intravenous misuse."
Designed for recovery and safety Bill Nelles, an addiction counselor who
sees more than 80 opioid-dependent patients at a rural general practice on
Vancouver Island, British Columbia, describes SUBOXONE as a new intervention
that will bring much needed choice to patients who rely on medical treatment
as part of their recovery plan.
"When patients first enter treatment, our main goal is to stabilize them
physically and socially, enabling them to remain in treatment," said Mr.
Nelles. "With SUBOXONE now available for opioid dependent patients in Canada,
this new treatment option can help them start taking control of their disease
and help them get on - and stay on - the road to recovery."
SUBOXONE combines buprenorphine with naloxone.(iv) Buprenorphine, a
partial opioid agonist, helps to manage the cravings associated with opioid
withdrawal.(i) The naloxone component of SUBOXONE reduces the potential for
misuse(iv) by causing unpleasant withdrawal symptoms if the product is misused
by intravenous injection.(v)
Treatment may include take-home doses after a period of two months, based
upon an assessment of the patient's clinical stability, and their ability to
safely store the product at home.
"The availability of SUBOXONE in Canada is a part of a long-awaited
solution to our need for a new treatment option for our patients," said Dr.
Marsh. "It's important to have a new choice, and arming physicians with
another weapon to fight opioid dependence will only serve to help patients
manage this disease."
To help ensure appropriate use of SUBOXONE, Schering-Plough Canada is
also offering an online education program, accredited by The College of Family
Physicians of Canada, for healthcare professionals. The program provides
professionals with information needed for product use, supports the dialogue
between patient and physician about the risk and benefits of therapy and
encourages an approach to care involving the careful monitoring of patients
within a framework of medical, social and psychological support as part of a
comprehensive opioid dependence treatment program.(iv) Schering-Plough is
dedicated to improving patient access to treatment for this disease. SUBOXONE
should only be prescribed by physicians who have experience in the
substitution treatment in opioid drug dependence, and have completed the
accredited SUBOXONE Education Program. Physicians can obtain more information
about the SUBOXONE Education Program by calling 1-800-463-5442 or visiting
Opioid dependence in Canada
Only one-quarter (25 per cent) of Canadians who are dependent on opioid
drugs, are in treatment.(iii) Illegal drug use represents an estimated annual
cost to society of more than $8.2 billion (in terms of burden on services such
as health care and law enforcement, the loss of productivity in the workplace
or at home resulting from disability and premature death).(vi) Over the last
decade, a change in illicit drug use has been noted with more drug users
abusing prescription opioid drugs, such as hydromorphone and oxycodone.(vii)
These prescription opioid drugs come either directly or indirectly from the
medical system, rather than from illicit production and distribution.(viii)
Approved by Health Canada in May, 2007(ix), SUBOXONE is indicated for
substitution treatment of opioid drug dependence in adults. The intention of
the naloxone component is to deter intravenous misuse. Patients prescribed
SUBOXONE should be carefully monitored within a framework of medical, social
and psychological support as part of a comprehensive opioid dependence
treatment program.(iv) The approval is based on results of a four-week
safety/efficacy study in 326 subjects with a maximum daily dose of 16 mg and a
48-week open-label safety study involving 461 patients.(*) SUBOXONE is taken
once a day as a sublingual tablet placed under the tongue to dissolve.(iv)
SUBOXONE sublingual tablets should only be prescribed by physicians who
have experience in substitution treatment in opioid drug dependence and have
completed an accredited SUBOXONE Education Program. SUBOXONE is a narcotic and
appropriate security measures should be taken to safeguard stocks of SUBOXONE
against diversion. Abuse and diversion of buprenorphine have been reported.
Physicians should not prescribe SUBOXONE sublingual tablets unless the
condition of daily intake supervised by a healthcare professional can be
ensured, except for week-ends and holidays, for a minimum of two months and
until the patient is clinically stable and able to safely store SUBOXONE take
The most common treatment-related adverse events reported during clinical
trials with SUBOXONE were those related to withdrawal symptoms (e.g.,
abdominal pain, diarrhea, muscle aches, anxiety, sweating).(iv)
Additional safety information
The safety and efficacy of SUBOXONE have not been established in patients
under 18 years of age and over 65 years of age. SUBOXONE should not be
administered to women who are pregnant or who are breast-feeding or to
patients who have severe respiratory insufficiency, severe hepatic
insufficiency, acute alcoholism, or delirium tremens. SUBOXONE should not be
taken together with alcoholic drinks or medications containing alcohol.
Alcohol increases the sedative effect of buprenorphine. SUBOXONE should be
used cautiously together with benzodiazepines as this combination may result
in death due to respiratory depression of central origin, therefore, dosage
reduction of one or both medications must be considered. Unless the
benzodiazepines are prescribed by a physician, this combination should be
avoided due to the risk of misuse. Patients should be warned of the potential
danger of the self-administration of other Central Nervous System depressants.
SUBOXONE can produce drug dependence of the opiate type.(iv)
Schering-Plough Canada Inc. is a country operation of Schering-Plough
Corporation that employs over 950 people across Canada. Schering-Plough Canada
Inc.'s web site is www.schering-plough.ca.
Schering-Plough is an innovation-driven, science-centered global health
care company. Through its own biopharmaceutical research and collaborations
with partners, Schering-Plough creates therapies that help save and improve
lives around the world. The company applies its research-and-development
platform to human prescription and consumer products as well as to animal
health products. In November 2007, Schering-Plough acquired Organon
BioSciences, with its Organon human health and Intervet animal health
businesses, marking a pivotal step in the company's ongoing transformation.
Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors,
patients, customers and other stakeholders served by its approximately
50,000 people around the world. The company is based in Kenilworth, N.J.,
U.S.A. and its Web site is www.schering-plough.com.
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DATE OF FEED: Tuesday, December, 11, 2007
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(i) Buprenorphine Sublingual and Buprenorphine and Naloxone Sublingual.
Medline Plus Web site. Available at:
www.nlm.nih.gov/medlineplus/druginfo/medmaster/a605002.html. Accessed Oct. 3,
(ii) Fischer B, Cruz MF, Rehm J. Illicit Opioid Use and Its Key
Characteristics: A Select Overview and Evidence from a Canadian Multi-site
Cohort of Illicit Opioid Users (OPICAN). Can J Psychiatry 2006;51(10):624-634.
(iii) Fischer B, Chin AT, Kuo I, et al. Canadian illicit opiate users'
views on methadone and other opiate prescription treatment: an exploratory
qualitative study. Subst Use Misuse 2002;37:495-522.
(iv) SUBOXONE (buprenorphine/naloxone) Product Monograph, Schering-Plough
Canada Inc.; May 2007.
(v) Subutex and Suboxone Approved to Treat Opiate Dependence. U.S. Food
and Drug Administration Web site. Available at:
www.fda.gov/bbs/topics/ANSWERS/2002/ANS01165.html. Accessed July 27, 2007.
(vi) Rehm J, Baliunas D, Brochu S, et al. The Costs of Substance Abuse in
Canada 2002. Ottawa, ON: Canadian Centre on Substance Abuse; 2006:1. Available
.pdf. Accessed August 30, 2007.
(vii) Haydon E, Rehm J, Fischer B, et al. Prescription drug abuse in
Canada and the diversion of prescription drugs into the illicit drug market
(Commentary). Can J Public Health 2005;96(6):459-61
(viii) Fischer B, Rehm J, Patra J, et al. Changes in illicit opioid use
across Canada. CMAJ 2006;175(11):1385-1387.
(ix) Notice of Compliance Information. Health Canada Web site. Available
at: www.nocdatabase.ca/. Accessed July 6, 2007.
(*) Fudala PJ, Bridge TP, Herbert S, et al. Office-based treatment of
opiate addiction with a sublingual-tablet formulation of buprenorphine and
naloxone. N Engl J Med 2003;349:949-958.
For further information:
For further information: Julie Wu, Schering-Plough Canada Inc., (514)
426-7300, firstname.lastname@example.org; Jilda Lazer/Kyle Rooks, Cohn & Wolfe, (416)
924-5700 ext. 4057/4098, email@example.com, firstname.lastname@example.org