Roughly
two decades of NIDA-sponsored research and clinical trials have
culminated in the Food and Drug Administration's (FDA) approval
of buprenorphine as a treatment for opiate dependence and addiction.
The medication was developed through a Cooperative Research and
Development Agreement between NIDA and the firm Reckitt Benckiser,
Inc.
Buprenorphine and the combination buprenorphine/naloxone are
the first medications approved under the Drug Abuse Treatment
Act of 2000 (DATA), which allows for office-based treatment of
opiate addiction. Under the terms of DATA, physicians providing
treatment must complete special training to dispense the medications,
must agree to treat no more than 30 patients at a time in an
office setting, and must refer patients to appropriate counseling
and support services to enhance pharmacological treatment.
The FDA action will permit physicians to prescribe buprenorphine
as part of office-based practice, making it possible for patients
dependent on heroin or prescription painkillers such as OxyContin
to receive treatment in their doctors' offices rather than requiring
daily visits to a centralized methadone clinic. Patients entering
or continuing treatment in clinic settings would also be eligible
to receive the new medications.
The availability of an effective medication that can be provided
in an office-based setting will significantly increase the number
of patients receiving treatment, according to Dr. Frank Vocci,
director of NIDA's Division of Treatment Research and Development. "Nearly
1 million Americans are dependent on opiates, but only 200,000
of them are getting treatment in licensed methadone clinics.
Approval of this medication means that many more people who want
treatment can get it," Dr. Vocci says. "FDA approval of this
medication marks a truly great moment in the treatment of drug
dependence and addiction, and it clearly shows the value of collaborative
partnerships between legislators, Federal agencies, and private
industry."
Buprenorphine is pharmacologically related to morphine and is
a partial opioid agonist: It has the same effect on mu opiod
receptors in the brain as does heroin or other opiate drugs,
but it has a lower maximum effect. Buprenorphine reduces or eliminates
withdrawal symptoms associated with opioid dependence but is
not strong enough to produce the euphoria and sedation caused
by heroin or other opiates. Increasing the dose of buprenorphine
does not enhance the drug effects, however, so the medication
is unlikely to be abused.
FDA approved two forms of the medication. Buprenorphine alone
will be prescribed (under the trade name Subutex) for patients
in the early stages of treatment. Buprenorphine combined with
naloxone, an opioid antagonist, will be prescribed (as Suboxone)
for long-term maintenance therapy that will allow patients to
resume and maintain normal, productive lives during treatment.
Combining the antagonist naloxone with buprenorphine further
reduces the potential that the medication could be abused; injecting
the combined formulation triggers withdrawal symptoms. Subutex
and Suboxone will be provided in tablet form as take-home medications.
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