In the face of a growing opioid-abuse epidemic, the FDA is considering a system of implanted rods that offer controlled release of buprenorphine—a drug already used in other forms to treat opioid addiction. Because it’s implanted in the skin, this version of the drug can’t easily be sold on the illegal market, proponents say—a key treatment advantage. The FDA is expected to decide whether to approve the device within a week.
The buprenorphine implant system, called Probuphine, includes four rods, each about the size of a match stick. The implants are inserted under the skin by a trained doctor and are left in place for six months.
The device doesn’t work for everyone, however. During a clinical study, 12% of patients who had implants relapsed. But the relapse rate for the pill version of the drug was 28%.
An FDA advisory committee voted 12–5 in favor of approving the implants in January, and a final decision from the agency is expected by May 27.
A major drawback to using the implants is the cost. The device’s manufacturer, Braeburn Pharmaceuticals, says it will price the implants to be competitive with other injectable treatments used to fight opioid addiction, including a shot that costs about $1,000 a month. In comparison, buprenorphine pills typically cost $130 to $190 for a month’s supply. The company says it will offer rebates to make sure appropriate patients can get access to the implants.
Probuphine was developed using ProNeura, a continuous drug delivery system that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate (EVA) and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper arm in an outpatient office procedure, and removed in a similar manner at the end of the treatment period.
Sources: Kaiser Health News; May 25, 2016; and Braeburn Pharmaceuticals; January 12, 2016.