Drugs approved for opiate dependence – Updates

Drugs approved for opiate dependence – Updates – Subutex and Suboxone

The FDA has approved two new products to treat opiate dependence.

In October 2002, the FDA approved Subutex and Suboxone tablets, which work by preventing symptoms of withdrawal from heroin and other opiates.

The new products represent two new formulations of buprenorphine. Subutex (buprenorphine hydrochloride) is intended for use at the beginning of drug abuse treatment. Suboxone (buprenorphine hydrochloride and naloxone hydrochloride) is intended to be the formulation used in maintenance treatment for opiate addiction. Naloxone was added to Suboxone to guard against intravenous abuse of buprenorphine.

Both drugs are supplied in 2 milligram and 8 milligram tablets, which are placed under the tongue and must be allowed to dissolve.

Subutex and Suboxone were studied in more than 2,000 people and shown to be safe and effective treatments. Side effects most commonly seen with both drugs include cold- or flu-like symptoms, headaches, sweating, sleeping difficulties, nausea, and mood swings. These effects usually peak in the beginning of treatment and may last a number of weeks.

Clinical data indicate that the risk of serious diminished breathing may be less with buprenorphine than other opioids when used in high doses or in overdose situations. Nonetheless, buprenorphine has been associated with deaths due to diminished breathing, especially when used with alcohol or other central nervous system depressant drugs, according to reports from France, where it has been available for several years.

Based on the potential for abuse of Subutex and Suboxone, the FDA and the U.S. Department of Health and Human Services recommended that the Drug Enforcement Administration (DEA) place the active ingredient buprenorphine in Schedule III under the Controlled Substances Act. Subutex and Suboxone are the first narcotic drugs available for the treatment of opiate dependence that can be prescribed in an office setting under the Drug Addiction Treatment Act of 2000. Subutex and Suboxone are manufactured by Reckitt Benckiser Healthcare in Hull, England.

COPYRIGHT 2003 U.S. Government Printing Office

COPYRIGHT 2004 Gale Group