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FDA Approves First Implant to Treat Opioid Addiction
The FDA has approved Probuphine (Titan Pharmaceuticals/Braeburn Pharmaceuticals), the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program.
Previously, buprenorphine was approved for the treatment of opioid dependence only as a pill or a film placed under the tongue or on the inside of a person’s cheek until it dissolved.
Probuphine consists of four, one-inch-long rods that are implanted under the skin on the inside of the upper arm. Only a health care provider who has completed specific training and has become certified through the Probuphine Risk Evaluation and Mitigation Strategy (REMS) program should insert and remove the implants. If further treatment is needed, new implants may be inserted in the opposite arm for one additional course of treatment. The FDA is requiring that postmarketing studies be conducted to establish the safety and feasibility of placing the Probuphine implants for additional courses of treatment.
The safety and efficacy of Probuphine were demonstrated in a randomized clinical trial of adults who met the clinical criteria for opioid dependence and were considered stable after prior buprenorphine treatment. Sixty-three percent of Probuphine-treated patients had no evidence of illicit opioid use throughout the six months of treatment––similar to the 64% of those who responded to sublingual buprenorphine.
The most common adverse events associated with Probuphine include implant-site pain, itching, and redness, as well as 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 less than 16 years of age. Clinical studies of Probuphine did not include participants older than 65 years of age.
The labeling for Probuphine includes a boxed warning that provides important safety information for health care professionals, including a warning that the insertion and removal of Probuphine are associated with the risk of implant migration, protrusion, expulsion, and nerve damage resulting from the procedure. Probuphine must be prescribed and dispensed according to the Probuphine REMS program because of the risks of surgical complications and because of the risks of accidental overdose, misuse, and abuse if an implant comes out or protrudes from the skin. As part of this program, Probuphine can be prescribed and dispensed only by health care providers who are certified with the REMS program and have completed live training, among other requirements.
Probuphine implants contain a significant amount of drug that can potentially be expelled or removed, resulting in the potential for accidental exposure or intentional misuse and abuse if the implant comes out of the skin. Patients should be seen during the first week after insertion, and a visit schedule of no less than once-monthly is recommended for continued counseling and psychosocial support.
Source: FDA; May 26, 2016