FDA Approves First-Ever Buprenorphine Implant To Treat Opioid Dependence

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FDA Approves First-Ever Buprenorphine Implant To Treat Opioid Dependence

By John Lavitt 05/31/16

The subdermal implant is intended for "clinically stable patients" taking low-to-moderate doses of other forms of buprenorphine. 

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FDA Approves First-Ever Buprenorphine Implant To Treat Opioid Dependence
The Probuphine implant Photo Braeburn Pharma

A subdermal implant that delivers a steady dose of buprenorphine could be available by late June for patients seeking an alternative treatment for opioid dependence. Last week, the Food and Drug Administration approved Probuphine—four rods, about the size of a matchstick, placed surgically beneath the skin, typically in the upper arm. 

Before this, buprenorphine—an ingredient of Suboxone, a maintenance drug used to wean dependent users off opioids by controlling cravings and painful withdrawal symptoms—was only available as a pill or a film placed under the tongue or the inside of the cheek. While maintenance drugs like Suboxone and methadone are generally effective, they are commonly diverted to the illegal drug marketplace and have become a popular drug of choice inside jails and prisons.

The Probuphine implant is designed to deliver a daily dose of buprenorphine over a six-month period, and is recommended by the FDA to be used as part of a multi-dimensional treatment approach that includes counseling and psychosocial support. The FDA also said in a release that the implant is intended for those who are already "stable on low-to-moderate doses of other forms of buprenorphine" as part of a treatment program.

"Maintenance medications can make all the difference in supporting a person’s stable recovery," said Dr. Nora Volkow, director of the National Institute on Drug Abuse, in a recent blog post. "I expect and hope that Probuphine will be a game-changer in how we fight opioid use disorder."

FDA Commissioner Dr. Robert M. Califf, said the agency is doing everything it can to "make new, innovative treatment options available that can help patients regain control over their lives." Approving Probuphine for patients is part of the FDA's efforts to support those seeking to "maintain treatment as part of their overall recovery program," he said in a release.

"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," said Volkow in the release. "This product will expand the treatment alternatives available to people suffering from an opioid use disorder."

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