An Implant to Treat Opioid Dependence

Probuphine is first buprenorphine implant approved by FDA

/ Author:  / Reviewed by: Anyssa Garza, PharmD

(RxWiki News) The US Food and Drug Administration (FDA) has approved the first buprenorphine implant for opioid dependence.

The implant is found under the brand name Probuphine. It's approved as a maintenance treatment for opioid dependence and is to be used as part of a complete treatment program that includes counseling and psychosocial support.

Probuphine is available as an implant that is surgically inserted under the skin on the inside of the upper arm. Probuphine consists of four one-inch rods. Once inserted, it will provide a constant low dose of buprenorphine. If after six months treatment is still warranted, Probuphine may be inserted in the opposite arm for an additional six months.

Prior to this approval, buprenorphine was only available as a pill or a film to be placed under the tongue or on the inside of the cheek. This implant offers an alternative to the pill or film, which could easily be forgotten, lost or stolen, according to the FDA.

When buprenorphine is given as part of a complete treatment program that includes other approved medications, it works to lessen opioid withdrawal symptoms and lessen the desire to use opioids.

Probuphine carries a boxed warning regarding the insertion and removal of the rods, which carries a risk of migration, protrusion, expulsion and nerve damage.

In addition, if the rod comes out or protrudes from the skin, accidental overdose, misuse and abuse could occur. That said, Probuphine is to be prescribed and dispensed according to the Probuphine REMS program. As part of the REMS program, patients can only be prescribed and dispensed Probuphine by health care providers who are certified with the REMS program and have completed all training requirements.

Reviewed by: 
Review Date: 
May 27, 2016
Last Updated:
May 31, 2016