The FDA just approved an implantable device designed to help heroin addicts kick their habit.
The new device, known as probuphine, could some day bring renewed health to the some 2 million Americans living with an opioid addiction.
Similar to an implantable contraceptive device, probuphine works by emitting low, steady doses of the drug buprenorphine to quiet addicts’ cravings over time, reduce withdrawal symptoms, and cut the risk of relapse.
Not all addicts can benefit from probuphine at the moment. Braeburn Pharmaceuticals, the company that markets the device, currently only has data to support the use of the device among people whose addictions are already stabilised on low-dose buprenorophine, which has been available since 2002.
As a way to care for people with opioid addictions, however, probuphine stands as a promising alternative to traditional forms of drug delivery.
Currently, buprenorphine is only available in pill form or as dissolvable tablets that get placed under the tongue. While effective, these solutions open the door for addicts to sell their buprenorphine for drug money. Used improperly, people can even overdose.
Probuphine could offer an alternate solution that skates around some of these problems.
The entire device can be inserted or removed in approximately 15 minutes, and works similarly to a contraceptive implant: Probuphine doles out small amounts of the key drug over a period of six months.
While the majority of the FDA’s advisory committee pushed for approval, the handful of dissenters pointed to a lack of proven safety and effectiveness in probuphine as reasons not to move forward.
“It is disappointing that the advisory committee set such a low bar for safety and effectiveness,” Tracy Rupp, director of public health policy initiatives at the National Center for Health Research, told USA Today. “Is probuphine effective? We still don’t know because the study was poorly designed and missing data.”
For Rupp and the several others who objected, not having any data past the six-month mark was disquieting, as many addicts need to stay on their medicine for years. Braeburn’s data was also racially skewed — 84% of the trial subjects were white.
By the CDC’s account, America’s heroin epidemic has seen its biggest surge in the last 10 years. Between 1999-2013, the death rate from prescription painkiller overdose more than quadrupled. The damage is so pervasive that even the rate of newborn babies born with heroin dependencies has risen: Between 2003 and 2013, the rate has climbed 500%.
So if an implant even helps a little bit, it will be a big deal.