Probuphine, the first buprenorphine implant designed for the maintenance treatment of opioid dependence has been approved by the U.S. FDA. The implant will provide a constant, low-level dose of buprenorphine for 6 months in patients who are stable on low-to-moderate forms of buprenorphine as part of a larger medication-assisted treatment program.
Buprenorphine has previously only been prescribed as a pill or as a dissolvable film placed under the tongue or on the inside of an individual’s cheek. While these forms of administration have been effective, worries have been aired with regards to the ability for these medication forms to be lost, forgotten or stolen.
The new implant consists of four, 1 inch rods inserted under the skin on the inside of the upper arm. The novel technique provides a unique opportunity for a six month course of treatment, improving patient convenience by removing the need to take medication 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,” commented FDA Commissioner Robert M. Califf. “Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.”
The clinical trial of Probuphine involved adults meeting the clinical criteria of opioid dependence and who were classified as stable following prior treatment with buprenorphine. Urine screening and self-reporting of opioid misuse during the 6 month period were used as measures of response to the treatment regime. Results indicated that 63% of Probuphine-treated patients did not misuse opioids during the trial, which was similar to the proportion of patients that responded to sublingual (under the tongue) buprenorphine.
In the evaluation of safety, the most common side effects of the use of Probuphine included pain, itching and redness at the site of implant, as well as headache, depression, constipation, nausea, vomiting, back pain, toothache and oropharyngeal pain.
The approval of Probuphine feeds into the FDA’s opioid action plan, which is part of the U.S. Department of Health and Human Services’ Opioid Initiative aiming to reduce prescription opioid and heroin related overdoses, death and dependence.
Nora Volkow (National Institutes of Health) remarked: “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. This product will expand the treatment alternatives available to people suffering from an opioid use disorder.”
Source: U.S. FDA press release