FDA approves first buprenorphine implant for opioid dependence

The US Food and Drug Administration (FDA), which is responsible for evaluating the safety and efficacy of medicines in the United States, has approved the first buprenorphine implant for the maintenance treatment of opioid dependence in adults, a treatment that is being hailed as “a game changer”.

Probuphine, which is marketed by Titan Pharmaceuticals and Braeburn Pharmaceuticals, consists of four, one-inch-long rods that are implanted under the skin in the upper arm. The treatment has been approved for use in patients who are already stable on low-to-moderate doses of other forms of buprenorphine (8mg or less a day) as part of a complete treatment programme that includes counselling and psychosocial support.

Previous buprenorphine treatment for opioid dependence is approved only as a pill or film, which needs to be placed under the tongue or inside a person’s cheek until it dissolved, and therefore doses can be easily forgotten, lost or stolen. Taking the implant eliminates these risks because it provides a constant, low-level dose of buprenorphine for six months.

If further treatment is required after six months, the FDA says one additional course of Probuphine may be inserted in the patient’s opposite arm.

Only certified doctors trained through the Probuphine risk evaluation and mitigation strategy programme will be able to insert and remove the implants, which will come with a boxed warning that says its insertion and removal are associated with the risk of implant migration, protrusion, expulsion and nerve damage resulting from the procedure.

The 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. As a result, the FDA recommends that patients are seen during the first week after insertion and at least once a month thereafter for continued counselling and support.