On May 26, the U.S. Food and Drug Administration (FDA) approved Probuphine, the first implant for the treatment of opioid addiction. It works by releasing a constant, low-level dose of buprenorphine (an already-approved medication in pill and film form that's used to treat opioid addiction) for six months via four, one-inch-long rods that are implanted under the skin on the inside of the upper arm.
Drug overdose is the leading cause of accidental death in the United States, according to the American Society of Addiction Medicine, and opioid addiction is leading the charge. The number of American deaths from opioid overdose (including both prescription opioid pain relievers and heroin) has nearly quadrupled since 1999, killing more than 28,000 people in 2014, according to the Centers for Disease Control and Prevention.
"Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives," said FDA Commissioner Robert M. Califf, MD, in a press release. "Today's approval provides the first-ever implantable option to support patients' efforts to maintain treatment as part of their overall recovery program."
A Step in the Right Direction, But a Long Way Still to Go
"On the surface, this treatment looks good, but there are a number of controversies," says Indra Cidambi, MD, certified addiction psychiatrist and medical director at Center for Network Therapy, New Jersey's first licensed outpatient detox facility.
For starters, the implant was designed to eliminate an ongoing issue with the current pill and film forms of buprenorphine: they could be lost, stolen, or even sold by the patient for pain medication or street drugs like heroin.
"[The implant] sounds beautiful, but when I talked to my sober patients about this new treatment, they were laughing," Dr. Cidambi says. "About 90 percent of them said they could scrape it out from underneath the skin, and sell two of those rods and keep two for themselves. So the mentality remains the same."
Even though the FDA says this therapy "should be used as part of a complete treatment program," Cidambi believes the six-month expiration date will make it more likely for patients to go without counseling.
"[Their thought process may be], 'I don't give a damn what you want to say, I'll see you in six months,'" she says. "That's a formula for failure. These patients need consistent monitoring, and if they don't have that, Probuphine is not going to fix the problem. It will just add on to it."
While Cidambi agrees that the concept of a continuous drip of medicine into the patient's bloodstream has the potential to be effective, "the processes related to dispensation of the medication make it impractical."
She explains that only a small percentage of medical professionals (about 25 percent) who prescribe buprenorphine have surgical training. "While Probuphine's manufacturer expects doctors to undergo training to learn to implant this treatment, it's hard to envision this happening," she says.
Complications, such as a physician's malpractice insurance and working from an office that's inadequate for surgical procedures, would also need to be addressed.
The results from the initial clinical trial have Cidambi concerned, as well. She says that out of the 15 participants who were instructed to insert and remove the four implants, seven of them performed it successfully, while the remaining eight "followed proper procedure."
"What this means is that eight of them couldn't remove it, even though they followed the procedure," Cidambi explains. "If this happened during a trial, what is going to happen in the community?"
Also, during the removal process, the rods might go missing. "This is the icing on the cake for me," she says. "If the surgeon cannot locate any of those four rods, they'll need to send the patient for imaging studies, like an ultrasound, until they find where the rod is in the body. And then it will need to be removed. So what are we looking at? How can this be helpful? It's mind-boggling, really."
Overall, she questions the safety and effectiveness of this treatment. "The FDA is saying this a fix for the diversion, but they need to look at the bigger picture."