A matchstick-size arm implant called Probuphine has been approved by the U.S. Food and Drug Administration to treat addiction to opioids, such as heroin and OxyContin, providing new hope for the fight against a condition that is very difficult to manage. The implant emits buprenorphine, a drug commonly used to treat opioid addiction.
Buprenorphine had previously been used in tablet form, or as a film that dissolves in the mouth. It works by blocking cravings and withdrawal symptoms, although it does not cause the feeling of euphoria that people accustomed to opioid drugs experience.
The problem with the oral method of administering buprenorphine is that sometimes addicts run out of the medication, or skip their doses and use illegal opioids instead. Sometimes they sell their medication to other addicts. This behavior is impossible with the implant.
Marvin Seppala, who is chief medical office at Hazelden Betty Ford Foundation, said, “For someone with an opioid-use disorder, they have to decide on a daily basis if they’re going to take their buprenorphine. That decision every day to remain abstinent from opioids is difficult. The implant takes away that decision.”
A clinical study involving 175 people tested the implant. All had been taking the oral form of buprenorphine for at least 6 months. Lead investigator of the trial, Richard Rosenthal, said one of the biggest values in Probuphine is that it provides a steady level of medication, avoiding the highs and lows that can increase craving and lead to relapse. Rosenthal said that the trial showed a significantly higher number of people treated with the implant staying off illicit opioids for the 6 months of the study when compared to those on the oral version of the drug.
The Obama administration has been pushing to promote medication for opioid addiction, and public health officials say better treatment is desperately needed as opioid abuse grows. According to the Centers for Disease Control and Prevention (CDC), more than 47,000 Americans died of drug overdoses in 2014, and the biggest contributor to those deaths were heroin and opioid painkillers.
There is a stigma about treating addiction with medication that can be hard to overcome for many users. Yngvild Olsen, chair of the public policy committee at the American Society of Addiction Medicine, says many addicts are told by judges, family members or health-care providers that using medication as part of their treatment is essentially substituting one addiction for another, and that medication use means they aren’t totally “clean.” Many rehab centers still offer only abstinence-based treatment.
Approval for the arm implant has been granted for people who are already stable on a moderate or low dose of oral buprenorphine. The FDA says it should be used along with psychosocial support and counseling. Health-care providers need to complete a training program on how to insert the implants before they can be certified to administer them.
Four arm implants are inserted into the upper arm at a time, providing 6 months of treatment. The most common side effects are itching and redness at the implant site, pain, headache and depression.
According to the implant’s marketer, Braeburn Pharmaceuticals, Probuphine would cost less than $6,000 for a 6-month supply, a hefty price tag. In addition to the cost, critics consider the buprenorphine arm implant to be largely unproven. Some point out that some of the clinical trial participants needed additional quantities of the drug for relief, suggesting that the implant dose is too low.