On the surface, it sounds like a great idea – a buprenorphine implant that can deliver sustained doses of medication-assisted therapy (MAT) for opioid dependence.
There are some obvious benefits, like not having to remember when to take your pill or film, not being tempted to sell it for other drugs, and not having to deal with the risk of having the pills or film stolen from you.
But even under ideal situations, this new implant—dubbed Probuphine—isn’t for everyone. It’s only available for patients who already are stable and on low to moderate doses of the drug. It’s also intended to be used alongside a comprehensive treatment program, which should always include counseling and group support.
“Scientific evidence suggests that maintenance treatment with these medications in the context of behavioral treatment and recovery support are more effective in the treatment of opioid use disorder than short-term detoxification programs aimed at abstinence,” said Dr. Nora Volkow, director of the National Institute on Drug Abuse, in a news release issued by the U.S. Food & Drug Administration.1 “This product will expand the treatment alternatives available to people suffering from an opioid use disorder.”
The implant lasts for six months. If a second implant is needed, it can go in the opposite arm. Beyond one year’s use, however, the FDA “is requiring postmarketing studies to establish the safety and feasibility of placing the Probuphine implants for additional courses of treatment.”
So will the implant be a practical alternative to pills or films? Probuphine must be prescribed and dispensed by healthcare providers who complete a Probuphine Risk Evaluation and Mitigation Strategy (REMS). The implants must be inserted correctly or there is a risk of “implant migration, protrusion, expulsion and nerve damage resulting from the procedure,” according to the FDA. “Probuphine must be prescribed and dispensed according to the Probuphine REMS program because of the risks of surgical complications and because of the risks of accidental overdose, misuse and abuse if an implant comes out or protrudes from the skin.”
Addiction Psychiatrist: Implant Could Lead to More Drug Abuse
Dr. Indra Cidambi, medical director at Center for Network Therapy in New Jersey, is skeptical about the new implant. For starters, it can make mixing the opioid with other drugs, such as benzodiazepines, more likely, especially if clients who use the implant do not participate in counseling and undergo drug screens. Opioids and benzodiazepines mixed together can be a recipe for death.
Cidambi, a board-certified addiction psychiatrist, is also skeptical about whether the implant will offer those dependent on opioids a large enough dose to discourage illegal drug use. The implant is recommended for people requiring eight milligrams of buprenorphine or less daily. “It’s possible that an individual in recovery may seek opiates on the streets in order to satisfy cravings or avoid withdrawal,” she said in a news release.2 “Probuphine will ‘incentivize’ patients not to attend counseling in conjunction with medication assisted treatment, as they have to see their doctor only once every six months. This may inhibit their recovery as they ignore the lifestyle changes they need to make and rely solely on medication.”
Doctors May Not Want to Suddenly Become Surgeons, Too
There also is a big hurdle for prescribers to overcome—becoming surgeons. “Probuphine requires a physician with some level of surgical skill to implant the medication under the skin,” Cidambi said in a news release. “While Probuphine’s manufacturer expects doctors prescribing buprenorphine to undergo training to learn to implant Probuphine, it is hard to envision this happening—a physician’s office may not be set up to perform a surgical procedure. A physician may not want to deal with complications resulting from such procedures; and participating physicians’ malpractice insurance rates may be negatively impacted due to inclusion of surgical procedures.”
Cidambi said a more likely scenario would be a “cumbersome” situation of “divided care.” She adds, “In that scenario, the prescriber (likely an addiction specialist) would have to be present when the surgeon (or equivalent) performs the procedure, which would create logistical headaches.”
Cidambi added that removing the implants proved difficult in a clinical trial, and federally mandated accounting systems for the drug would be “unpalatable” because of additional paperwork required by healthcare providers.
Still, FDA Commissioner Dr. Robert M. Califf said the implant offers a new way to support those using maintenance treatment as part of their recovery. “Opioid abuse and addiction have taken a devastating toll on American families,” he said in a news release. “We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives.”
1. FDA approves first buprenorphine implant for treatment of opioid dependence. (26 May 2016). U.S. Food and Drug Administration press release. Retrieved June 8, 2016, from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm503719.htm
2. Cidambi, I. (26 May 2016) Probuphine: Formidable hurdles will severely limit adoption. PR Web press release. Retrieved June 8, 2016, from http://www.prweb.com/releases/2016/05/prweb13447603.htm
Written by David Heitz