The FDA has approved Probuphine, the first buprenorphine implant for treating patients with opioid dependence.
The implant provides a constant, low-level dose of buprenorphine for 6 months and is indicated for use in patients who are stable on low-to-moderate doses of other forms of the drug. An independent FDA advisory committee had supported Probuphine’s approval earlier this year.
“Scientific evidence suggests that maintenance treatment with [methadone, buprenorphine, or naltrexone] 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,” commented Nora Volkow, MD, director of the National Institute on Drug Abuse. “This product will expand the treatment alternatives available to people suffering from an opioid use disorder.”
The FDA advises that Probuphine (Titan Pharmaceuticals Inc. and Braeburn Pharmaceuticals) should be used as part of a complete treatment program that includes counseling and psychosocial support. Administering Probuphine can only be done by a healthcare provider who has completed training and has become certified through a restricted program (Probuphine Risk Evaluation and Mitigation Strategy).
“Opioid abuse and addiction have taken a devastating toll on American families,” stated Robert M. Califf, MD, FDA commissioner. “We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives. [This] approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.”
A randomized clinical trial demonstrated safety and efficacy among adults who met the clinical criteria for opioid dependence and were considered stable after prior buprenorphine treatment. The study found that 63% of Probuphine-treated patients had no evidence of illicit opioid use during 6 months of treatment. This was comparable to 64% of patients who responded to sublingual buprenorphine alone.
The most common side effects associated with use of the implant include implant-site pain, itching, and redness, followed by headache, depression, constipation, nausea, vomiting, back pain, toothache, and oropharyngeal pain. The safety and efficacy of Probuphine have not been established in children or adolescents younger than 16 years of age, and studies did not include participants older than age 65.
Probuphine has a boxed warning that provides important safety information for healthcare professionals, which notes that insertion and removal of Probuphine are associated with the risk of implant migration, protrusion, and expulsion, as well as nerve damage resulting from the procedure.
- FDA approves first buprenorphine implant for treatment of opioid dependence. Silver Spring, MD: US FDA. Published May 26, 2016. Available at: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm503719.htm