FDA Approves Implant for the Treatment of Opioid Dependence

The U.S. Food and Drug Administration approved the first buprenorphine implant for the maintenance treatment of opioid dependence. The implant, which consists of four, one-inch-long rods that are implanted under the skin on the inside of the upper arm, 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. The implant should be used as part of a complete opioid-dependence treatment program that includes counseling and psychosocial support.

The implant’s approval was based on the results of a randomized clinical trial of 287 adults who met clinical criteria for opioid dependence (defined as a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use, persisting in drug use despite harmful consequences, or tolerance or physical dependence on the drug) and were considered stable after prior buprenorphine treatment.

Patients were randomized to receive the buprenorphine implant, a placebo implant, or sub-lingual buprenorphine. Urine screenings and self-report of illicit opioid use during the six-month treatment period were used to measure outcomes. Sixty-three percent of patients with the buprenorphine implant had no evidence of illicit opioid use throughout the six months of treatment; similarly, 64 percent of those who responded to sublingual buprenorphine alone had no evidence of illicit opioid through six months.

The most common treatment-related adverse events included 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 the implant has not been established in children or adolescents <16 years or in those >65 years.

The implant carries a Boxed Warning that the insertion and removal of buprenorphine are associated with the risk of implant migration, protrusion, expulsion, and nerve damage resulting from the procedure. The implants contain a significant amount of buprenorphine 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. It is recommended that patients see their health-care provider during the first week after insertion.

Source: U.S. FDA press release, May 26, 2016.