Tag Archives: implanted medical device

FDA Advisory Panel Recommends Approval of Implanted Buprenorphine

FDALast week a Food and Drug Administration (FDA) advisory panel recommended the approval of a new medication designed to treat opiate addiction, called probuphine. While the main ingredient of the drug, buprenorphine, isn’t new, the controversial delivery method definitely is. The way the drug is administered is by implanting under the skin, where it then slowly releases lower doses of buprenorphine into the blood stream.

Currently, buprenorphine is one of the most popular medications to help alleviate the extreme cravings that are associated with heroin and prescription painkillers as well as to lessen the severity of withdrawal symptoms if used in a tapering process. With the continuation of the opioid epidemic, many physicians and treatment specialists welcome new methods of addressing this deadly issue.

Having an implanted device that controls the release of the drug allows for more precise administration as well as prevents skipping doses, thus theoretically reducing relapse. However, as critics pointed out, the information presented to the FDA wasn’t thorough enough.

“It is disappointing that the advisory committee set such a low bar for safety and effectiveness. Is probuphine effective? We still don’t know because the study was poorly designed and missing data,” said Tracy Rupp, a pharmacist and director of public health policy initiatives at the National Center for Health Research.

“This is not the real world of opioid addiction,” Rupp continued. “Many of these patients will require treatment for years. We need long-term safety data from diverse populations. Patients will require a new incision every 6 months, creating an ongoing risk of harm due to bleeding and infectious complications.”

There is a strong argument for medical intervention when it comes to opioid abuse, however probuphine may not be the answer. It appears that the FDA may be willing to move forward with the implant, but only with addicts who have been on buprenorphine stably and would benefit from the new way of administering it.