FDA Approves First Implant for Maintenance of Opioid Dependence

Subcutaneous buprenorphine implant (Probuphine) treats opioid dependence in patients who are already stable on low-to-moderate doses of other forms of buprenorphine.

The FDA today approved Titan Pharmaceuticals’ subcutaneous buprenorphine implant (Probuphine) for the maintenance treatment of opioid dependence in patients who are already stable on low-to-moderate doses of other forms of buprenorphine.

Probuphine consists of 4 rods, each an inch long, that are implanted under the skin on the inside of the upper arm; new implants may be inserted in the opposite arm if further treatment is required. Because the product must be administered surgically, only health care providers who have completed the Probuphine Risk Evaluation and Mitigation Strategy (REMS) are authorized to insert and remove the implants.

The first product of its kind to receive the FDA’s nod, Probuphine delivers a constant and low-level dose of buprenorphine over a 6-month period. While burprenophine was previously available only as a pill or a film, the new delivery method will enable patients to receive the drug without having to take it on a daily basis.

“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.”

The agency based its decision on data from a randomized clinicial trial in which Probuphine’s safety and efficacy was evaluated in patients aged 16 to 65 years with opioid dependency. After a 6-month treatment period, the research team found no evidence of illicit opioid use in 63% of those who received the implants, a comparable result to the 64% of participants who responded well to sublingual buprenorphine.

“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,” stated Nora Volkow, MD, director of the National Institute on Drug Abuse at the National Institutes of Health, in a press release. “This product will expand the treatment alternatives available to people suffering from an opioid use disorder.”

The most common adverse events associated with the use of Probuphine include headache, depression, constipation, nausea, vomiting, back pain, toothache, oropharyngeal pain, and implant-site pain, itching, and redness.

In addition, the drug is approved with a boxed warning alerting patients and prescribers to the risk of implant migration, protrusion, expulsion, and nerve damage linked to the insertion and removal of Probuphine.

The FDA also recommends that patients should be seen during the first week after insertion, and at least once a month thereafter, for continued counseling and psychosocial support.