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U.S. Department of Health and Human Services


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T02-38Media Inquiries: 301-827-6242
October 8, 2002Consumer Inquiries: 888-INFO-FDA

The Food and Drug Administration (FDA) announced the approval of Subutex (buprenorphine hydrochloride) and Suboxone tablets (buprenorphine hydrochloride and naloxone hydrochloride) for the treatment of opiate dependence. Subutex and Suboxone treat opiate addiction by preventing symptoms of withdrawal from heroin and other opiates.

These products represent two new formulations of buprenorphine. The first of these formulations, Subutex, contains only buprenorphine and is intended for use at the beginning of treatment for drug abuse. The other, Suboxone, contains both buprenorphine and the opiate antagonist naloxone, and is intended to be the formulation used in maintenance treatment of opiate addiction. Naloxone has been added to Suboxone to guard against intravenous abuse of buprenorphine by individuals physically dependent on opiates. Both drugs are supplied in 2 mg and 8 mg tablets which are placed under the tongue and must be allowed to dissolve.

Subutex and Suboxone have been studied in over 2,000 patients and shown to be safe and effective treatments for opiate dependence. Side effects most commonly seen with the use of 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 with Subutex or Suboxone and may last a number a 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 in combination with alcohol or other Central Nervous System (CNS) 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, FDA and its parent 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 (CSA). Buprenorphine is considered to have less risk for causing psychological and or physical dependence than the drugs in Schedule II such as morphine, oxycodone, fentanyl, or methadone.

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 (DATA) of 2000. Until recently, opiate dependence treatments in Schedule II, like methadone, could be dispensed in a very limited number of clinics that specialize in addiction treatment. As a consequence, there have not been enough addiction treatment centers to accommodate all patients desiring therapy. Under this new law, medications for the treatment of opiate dependence that are subject to less restrictive controls than those of Schedule II can be prescribed in a doctor's office by specially trained physicians. This change is expected to provide patients greater access to needed treatment.

The sponsor, in collaboration with the FDA and with input from other Health and Human Services agencies, has developed a comprehensive risk management program designed to deter abuse and diversion from its legitimate use in patients and physicians regarding proper use of these drugs, close monitoring of drug distribution channels, and child resistant packaging.

In addition, the provisions of the DATA include limits on the number of patients individual physicians are allowed to treat and special DEA registration for the use of this drug, thus providing additional safeguards as this drug enters the office-based treatment setting.

The risk management program also provides for active and passive surveillance to identify if and when the drugs are being abused. The surveillance will include interviews with substance abusers, monitoring local drug markets, data collection, and the monitoring of adverse event reports. Reports of the results of these surveillance efforts will enable FDA to identify untoward effects from the availability of buprenorphine and, if indicated, to take appropriate actions to protect the public health.

Subutex and Suboxone are manufactured by Reckitt Benckiser Pharmaceuticals