FDA Approval Pending for Implant to Treat Opioid Addiction

Sometime in the next two months the Food and Drug Administration is expected to decide whether to give the go-ahead for an implant designed to treat addiction to heroin or prescription painkillers.  Known as probuphine,  the implant releases medication that helps prevent withdrawal and reduces cravings over the course of six months.  An FDA advisory committee voted 12-5 to recommend its approval.  But the product has raised some safety concerns

The development of probuphine comes at a time when the White House, along with health organizations, are recommending the expanded use of medications to treat opiate addiction. The most effective medications are methadone and buprenorphine, commonly known as Suboxone. Both cut the risk of death from overdose in half and substantially reduce infections from IV drug use such as HIV and Hepatitis C, according to the Substance Abuse and Mental Health Services Administration.

Probuphine, says Behshad Sheldon, president and CEO of Braeburn Pharmaceuticals, delivers a steady dose of buprenorphine through four matchstick-size implants in a patient’s arm. […]

Insertion of probuphine under the skin takes about 15 minutes. Removal takes a little longer. And if it’s approved by the FDA doctors will have to be trained on how to do both.

What concerns pharmacist Tracy Rupp is the transition of  buprenorphine patients to the implant. Dr. Rupp is with the National Center for Health Research which analyzes health information. She says some patients on the implant needed to take additional doses of buprenorphine and she’d like to see further study about the risks and benefits for patients who make the switch.

“Patients in the implant group actually required a lot more extra oral doses of medication than what the patients who were just given the oral doses to begin with and so the question is, well what patients is this really appropriate for if they’re still going to need a whole lot of oral doses in addition to the implant?” she says. []

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