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Home » Drug Information » FDA Approved Drugs » 2002
Medical Areas: Pharmacology/Toxicology | Psychiatry/Psychology

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Subutex/Suboxone (buprenorphine/naloxone)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Reckitt Benckiser
Approval Status: Approved October 2002
Treatment Area: Opiate Dependence

General Information

Suboxone is a combination of two currently marketed medications, buprenorphine and naloxone. It will be used for the treatment of subjects with heroin and opiate addictions. Suboxone and Subutex were the first therapies approved for in-office prescribing under the federal Drug Addiction Treatment Act of 2000.

Suboxone and Subutex are prescribed in 2mg and 8mg oral tablets.

These products were developed under a Cooperative Research and Development Agreement between Reckitt Benckiser and the National Institutes of Health’s National Institute on Drug Abuse in the USA. Subutex first received marketing approval in France and was launched in February 1996 by Schering-Plough under licence from Reckitt Benckiser.

Clinical Results

Suboxone tablets have been studied in 575 patients, Subutex tablets in 1834 patients and buprenorphine sublingual solutions in 2470 patients. A total of 1270 females have received buprenorphine in clinical trials. Dosing recommendations are based on data from one trial of both tablet formulations and two trials of the ethanolic solution. All trials used buprenorphine in conjunction with psychosocial counseling as part of a comprehensive addiction treatment program. There have been no clinical studies conducted to assess the efficacy of buprenorphine as the only component of treatment.

In a double blind placebo- and active controlled study, 326 heroin-addicted subjects were randomly assigned to either Suboxone 16 mg per day, 16 mg Subutex per day or placebo tablets. The primary study comparison was to assess the efficacy of Subutex and Suboxone individually against placebo. The percentage of thrice-weekly urine samples that were negative for non-study opioids was statistically higher for both Subutex and Suboxone, than for placebo.

Side Effects

Adverse events associated with the use of Suboxone and Subutex may include (but are not limited to) the following:

  • Asthenia
  • Headache
  • Pain
  • Constipation
  • Nausea
  • Insomnia
  • Withdrawl Syndrome
  • Sweating
  • Chills
  • Rhinitis
  • Infection

Mechanism of Action

Suboxone offers a combination of a weak narcotic (buprenorphine) and a narcotic antagonist (naloxone). The latter is added to prevent addicts from injecting the tablets intravenously, as has happened with tablets only containing buprenorphine; because it contains naloxone, Suboxone is highly likely to produce intense withdrawal symptoms if misused intravenously by opioid-addicted individuals.

Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappaopioid receptor. Naloxone is an antagonist at the mu-opioid receptor.

Additional Information

For more information on Subutex & Suboxone, please visit The Suboxone Web Site

For more information on Reckitt Benckiser please visit www.reckittbenckiser.com