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JAMA
The first buprenorphine implant for maintenance treatment of opioid dependence has received FDA approval (http://1.usa.gov/1RuiaRi).
Previously, buprenorphine was approved for opioid dependence as a pill or film placed under the tongue or on the inside of the cheek until it dissolves. The pills and films are effective but can be lost, forgotten, or stolen. The 6-month implant may improve adherence for many people in recovery. It is intended for patients with prolonged clinical stability at a daily dose of 8 mg or less of oral buprenorphine.
Marketed as Probuphine, the implant consists of 4-inch–long rods placed under the skin on the inside of the upper arm. Specific training is required to learn how to surgically implant and remove the rods.
The implant should be used as part of a complete treatment program that includes counseling and psychosocial support. A comprehensive approach that combines approved medication—buprenorphine, methadone, or naltrexone—with counseling and other behavioral therapies can reduce withdrawal symptoms and the desire to use opioids. At sufficient doses, buprenorphine decreases the pleasurable effects of opioids, making continued abuse less attractive.
“Scientific evidence suggests that maintenance treatment with these medications in the context of behavioral treatment and recovery support are more effective in the treatment of opioid use disorder than short-term detoxification programs aimed at abstinence,” Nora Volkow, MD, director of the National Institute on Drug Abuse of the National Institutes of Health, said in a statement.
The most common adverse events associated with the implant include pain at the implant site, headache, depression, constipation, nausea, vomiting, back pain, toothache, and oropharyngeal pain. A boxed warning cautions that the implant may migrate, protrude through the skin, or cause nerve damage.