WASHINGTON—The U.S. Food and Drug Administration is expected to decide this week whether to approve a new weapon in the war against heroin and prescription opioid addiction.
The Probuphine implant by Braeburn Pharmaceuticals of Princeton, NJ, would be the first FDA-approved implant for opioid dependence and the longest-acting treatment to address the growing problem.
When inserted under the skin of the upper arm, four small, flexible Probuphine implants provide a continuous, six-month dose of buprenorphine, which helps curb the withdrawal symptoms and drug cravings that characterize opioid addiction. […]
Currently, buprenorphine for opioid dependence is available in the U.S. only in pill form and as a film that dissolves under the tongue. Both versions can be easily sold illegally, used by others and ingested accidentally by children.
Experts say implants lessen those risks and make it easier for patients to stick to their buprenorphine regimen. […]
Diana Zuckerman, president of the National Center for Health Research, a nonprofit education and advocacy group, said it’s unclear how safe and effective the implant is because there’s been only one major study – and it lasted only six months.
Opioid addiction is not a six-month problem,” Zuckerman said. “So you want to see what happens not only in the first six months, but in the next six months.”
At an FDA hearing in January, Tracy Rupp, the center’s director of public health policy initiatives, provided a list of reasons why the implant should not be approved.
In explaining the center’s position, Zuckerman said some trial participants with implants needed supplemental doses of buprenorphine film, suggesting the implant wasn’t helping them. But these patients weren’t counted as “nonresponders” to the implant, Zuckerman said.
In a statement, Braeburn said 82 percent of the trial patients who got the actual implant never required supplemental buprenorphine.