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President Bush Signs Bill Lifting Restriction on Office-Based Treatment With Buprenorphine for Opioid Dependence/Addiction

Posted on: Wednesday, 3 August 2005, 12:00 CDT

RICHMOND, Va., Aug. 3 /PRNewswire/ -- President Bush signs bill lifting restriction on office-based treatment with buprenorphine for opioid dependence/addiction.

WHAT: President Bush has signed into law an amendment to the Controlled Substances Act that will increase the availability of buprenorphine (Suboxone(R)) for the treatment of opioid dependence/addiction. This amendment removes the 30-patient limit on group medical practices that treat opioid dependence with buprenorphine. The restriction was part of the original Drug Addiction Treatment Act of 2000 (DATA) that allowed treatment of opioid dependence in a doctor's office. With this change, every certified doctor may now prescribe buprenorphine up to his or her individual physician limit of 30 patients. Today's action is a significant step forward in expanding treatment access to those who have the chronic disease of opioid dependence.

Each year, millions of ordinary Americans who are properly treated for pain become dependent on prescription opioid painkillers. Opioid dependence, whether on prescription painkillers or heroin, is a chronic brain disease that can have devastating consequences. Medical treatments for opioid dependence are available, and with the provisions of DATA that allow office-based treatment, physicians now can become certified to provide the same type of private, confidential in-office care for opioid dependence as they do for other chronic disease, such as diabetes or hypertension.

About Reckitt Benckiser Pharmaceuticals, Inc.

Reckitt Benckiser Pharmaceuticals is a specialty pharmaceutical company that manufactures and markets Suboxone(R) and Subutex(R), formulations of buprenorphine used to treat opioid dependence in a medical office-based setting. Suboxone and Subutex are the only products approved by the FDA for office-based treatment of opioid dependence. Reckitt Benckiser Pharmaceuticals is committed to expanding access to medical therapies for patients suffering from the chronic, relapsing brain disease of drug dependence. For more information, visit http://www.opioiddependence.com/. Reckitt Benckiser Pharmaceuticals, Inc. is a wholly owned subsidiary of Reckitt Benckiser PLC, a publicly traded UK firm.

Fair Balance

Intravenous misuse of buprenorphine, usually in combination with benzodiazepines or other CNS depressants has been associated with significant respiratory depression and death. Suboxone has 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 (a category C medication) in pregnancy. Due caution should be exercised when driving cars or operating machinery. The most commonly reported adverse events with Suboxone include 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%).

Suboxone is a registered trademark of Reckitt Benckiser Pharmaceuticals, Inc.

Feinstein Kean Healthcare Harriet Ullman (617) 577-8110 hullman@fkhealth.com

Reckitt Benckiser Pharmaceuticals, Inc.

CONTACT: Harriet Ullman of Feinstein Kean Healthcare, +1-617-577-8110,hullman@fkhealth.com

Web site: http://www.opioiddependence.com/

Source: PRNewswire

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