Industry Briefs

FDA Approves First Implant for Opioid Dependence

The Food and Drug Administration (FDA) last week approved the first buprenorphine implant for the maintenance treatment of opioid dependence.

The implant, known as Probuphine, is designed to be surgically placed under the skin inside the upper arm 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 medication-assistant treatment program.

A randomized clinical trial of adults aged 16 to 65 who met the clinical criteria for opioid dependence and were considered stable after prior buprenorphine treatment found 63 percent of patients treated with Probuphine had no evidence of illicit opioid use throughout six months of treatment—similar to the 64 percent of patients who responded to a daily sublingual form of the medication.

The most common side effects from treatment with Probuphine included headache, depression, constipation, and pain at the site of the implant.

Probuphine can be prescribed, dispensed, inserted, and removed only by health care providers who are certified in the Probuphine Risk Evaluation and Mitigation Strategy program and have completed additional training.

Probuphine is marketed by Titan Pharmaceuticals Inc. and Braeburn Pharmaceuticals. ■