First buprenorphine implant treatment for opioid dependence earns FDA approval
With the opioid addiction epidemic on the rise, health professionals want to broaden the availability and use of treatments that can fight the spread of addiction. This is a new top priority for federal health experts across the U.S.
"Opioid abuse and addiction have taken a devastating toll on American families,” FDA Commissioner Robert Califf said. “We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives. Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.”
Probuphine is the first implant to receive approval. It gives patients a low-level, constant dose of buprenorphine over a period of six months. It is specifically designed for patients who have low-to-moderate doses of different kinds of buprenorphine, which would make up an entire treatment program.
“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, director of the National Institute on Drug Abuse, said. “This product will expand the treatment alternatives available to people suffering from an opioid use disorder.”
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