Committee Recommends FDA Approval of Opioid Addiction Implant
Probuphine works like a contraceptive implant, with 4 small implanted rods that provide a steady amount of medication for up to 6 months. Photo: Braeburn Pharmaceuticals.
The Psychopharmacologic Drugs Advisory Committee has recommended that the Food and Drug Administration approve an implant for treating opioid addiction.
The committee voted 12 to 5 in favor of approving probuphine, the first long-acting, subdermal buprenorphine implant to treat addiction to opioids. Buprenorphine is currently only available either as a dissolvable film that is placed under the tongue, or a pill, which allows some addicts to sell their supplies to get money for drugs.
Because probuphine works like a contraceptive implant, with four small implanted rods that provide a steady amount of medication for up to six months, its manufacturer Braeburn Pharmaceuticals says the implant eliminates that risk.
"I think this will save some folks' lives," said advisory committee member David Pickar, MD, an adjunct professor of psychiatry at Johns Hopkins Medical School in Baltimore.
The implant is also designed to simplify receiving and prescribing treatment for opioid addiction. Methadone is only available at specialized clinics where patients must typically go every day to get a dose. Buprenorphine is considered safer because it is less likely to cause an overdose, but physicians must be certified to dispense the drug and can only treat 100 patients at a time.
Doctors who want to prescribe probuphine must either refer patients to providers who are trained to implant medical devices, or would have to receive training to learn how to safely implant and remove it, according to Behshad Sheldon, president and CEO of Braeburn Pharmaceuticals. Probuphine takes about 10 to 15 minutes to implant and about 20 minutes to remove.
Some committee members had concerns about the clinical trial testing probuphine. Tracy Rupp, PharmD, MPH, RD, director of public health policy initiatives at the National Center for Health Research, a nonpartisan group that analyzes health data, urged the committee to reject probuphine, noting that its manufacturer presented only 1 clinical study showing the drug was effective.