The FDA has approved a buprenorphine implant as a maintenance treatment for opioid dependence.
Probuphine, made up of four inch-long rods placed subdermally on the inside of the upper arm, is designed to deliver a steady dose of buprenorphine over a 6-month period. The implant is approved for patients who are already on low-to-moderate doses of other forms of buprenorphine. If additional treatment is needed, more rods can be implanted in the opposite arm.
In a clinical trial, nearly two-thirds of Probuphine users were able to refrain from using illicit opioids during the 6 months, comparable to users of sublingual buprenorphine.
Physicians must be certified to place and remove the implants. The product will contain a boxed warning about the risks of implant migration, protrusion, expulsion, and nerve damage related to insertion and removal.
An advisory committee to the FDA recommended that the agency approve the drug.