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.
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