If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  New Opiate Addiction Treatment, Subutex (Buprenorphine Hydrochloride), Approved by Health Canada MONTREAL, QC -- February 14, 2005 -- For the first time since 1961, patients in Canada will have access to a new and safe treatment for addiction to opiates such as heroin and prescription pain medication. Subutex® (buprenorphine hydrochloride), an oral medication that diminishes drug cravings, reduces withdrawal symptoms and blocks the effects of subsequent drug abuse, has been approved by Health Canada. Subutex will be available by the end of 2005, following education sessions for physicians. "This is a very welcome addition to our limited treatment toolbox for opiate-addicted patients," said Dr. David Marsh, president of the Canadian Society of Addiction Medicine. "I am pleased that this medication will soon be available. I am also happy to hear that there will be programs to educate physicians about treating this patient group." Of the more than 100,000 people addicted to opiates in Canada, only 25,000 are currently in treatment programs. The estimated social and economic cost to Canadian society of untreated opiate addiction was $1.4 billion in 1992 alone(i). This does not include the increased public health costs associated with the diagnosis and treatment of conditions such as Hepatitis C and HIV that are transmitted by intravenous drug use. While only one quarter of those addicted are in treatment programs, it is estimated that up to a further 25,000 would like to receive therapy but are reluctant to initiate methadone, the current standard. Existing treatment of opiate addiction with methadone is complicated by high relapse rates, risk of misuse and overdose. The social stigma of using methadone, widely known for the treatment of heroin addiction, as well as privacy issues encountered by patients in many cases may deter potential patients from existing therapy. A comparison of Subutex to methadone indicates that the possibility of fatal overdose with Subutex is limited as it exhibits a "ceiling effect" on opiate activity(ii). This means that even at high doses, Subutex could have a lower risk of respiratory depression. "We need to change the way we think about dependence and view opiate addiction as a disease that can be treated medically," said Dr. Douglas Gourlay, Medical Consultant, Centre for Addiction and Mental Health. "The public health and human toll of addiction are an enormous strain on Canada's health system and any new treatment that offers a safe and effective addition to the current standard is certainly very good news for both patients and physicians alike." In agreement with Health Canada and in collaboration with national addiction medicine associations, Schering has committed to the development and provision of educational sessions for physicians who wish to prescribe Subutex. The Subutex National Education Program has three core components for the safe and effective use of the therapy within a framework of medical, social and psychological support: 1. training of the prescribing physicians in the use of Subutex; 2. maintenance of a list of Subutex National Education Program trained physicians; and 3. daily dosing supervised by a healthcare professional. Subutex will be commercially available once these sessions have been completed, anticipated by the end of 2005. Clinical trials(ii) Subutex (buprenorphine hydrochloride), a partial opioid agonist, under conditions of daily intake supervised by a healthcare professional, is indicated for substitution treatment in opioid drug dependence in adults. Patients prescribed Subutex should be carefully monitored within a framework of medical, social, and psychological support as part of a comprehensive opioid dependence treatment program. The efficacy and safety of Subutex has been demonstrated in four clinical trials. All trials used Subutex in conjunction with psychosocial counseling and a comprehensive addiction treatment program. Subutex was demonstrated to be effective in reducing both the number of opiate positive urine samples and in retaining patients in treatment. The most common adverse events reported with Subutex were similar to placebo. These included headache, pain, abdominal pain, back pain, withdrawal syndrome, diarrhea, nausea, insomnia, rhinitis, and sweating. Constipation, typically associated with opiates, was also reported. As with other opioid agonists, there is a risk of respiratory depression.
Subutex(R) is a registered trademark of Reckitt Benckiser Healthcare (UK) Limited and is used under license by Schering Canada Inc. (i) Reducing the Harm Associated with Injection Drug Use in Canada, Prepared by F/P/T Advisory Committee on Population Health, F/P/T Committee on Alcohol and Other Drug Issues, F/P/T Advisory Committee on AIDS, and F/P/T Heads of Corrections Working Group on HIV/AIDS, September 2001. (ii) Product Monograph, Schering Canada Inc. SUBUTEX(R)
SOURCE: Schering Canada Inc.
|
