Subutex/Suboxone (buprenorphine/naloxone)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
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
