FDA Approves First-of-its-Kind Implant to Help Combat Opioid Dependence
The Food and Drug Administration (FDA) announced the approval of Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Until recently, buprenorphine had only been available in a sublingual tablet or film formulation. The new implant is designed to deliver a 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.
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. A response to medication-assisted treatment was measured by urine screening and self-reporting of illicit opioid use during the six month treatment period. 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 alone. The most common side effects from treatment include implant-site pain, itching, and redness, as well as headache, depression, constipation, nausea, vomiting, back pain, toothache and oropharyngeal pain.
Probuphine consists of four, one-inch-long rods that are implanted under the skin on the inside of the upper arm. Administering Probuphine requires specific training because it must be surgically inserted and removed. Only a clinician who has completed the training and become certified through a restricted program called 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 postmarketing studies to establish the safety and feasibility of placing the Probuphine implants for additional courses of treatment.
Probuphine has a boxed warning that provides important safety information, including a warning that insertion and removal are associated with the risk of implant migration, protrusion, expulsion and nerve damage resulting from the procedure. Because of the risks of surgical complications and the risks associated with accidental overdose, misuse and abuse if an implant comes out or protrudes from the skin, Probuphine can only be prescribed and dispensed by clinicians who are certified with the REMS program and have completed live training, among other requirements. 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.
In a meeting held earlier this year, an independent FDA advisory committee supported the approval of Probuphine