Public Release: 

Medication implant may improve opioid abstinence among adults with opioid dependence

The JAMA Network Journals

In a study appearing in the July 19 issue of JAMA, Richard N. Rosenthal, M.D., of the Icahn School of Medicine at Mount Sinai, New York, and colleagues examined if 6-month subdermal buprenorphine implants maintained low to no illicit opioid use relative to daily sublingual (beneath the tongue) buprenorphine among currently stable opioid-dependent patients receiving buprenorphine maintenance treatment.

Opioid dependence is a growing public health concern in the United States, associated with spread of human immunodeficiency virus and hepatitis C and fatal over dose when left untreated. The effectiveness of treatment with the medication buprenorphine is limited by suboptimal adherence. In this study, 177 opioid-dependent patients with stable abstinence were randomly assigned to sublingual buprenorphine with placebo implants (n = 90) or buprenorphine implants with sublingual placebo (n = 87); 165 of 177 patients (93 percent) completed the trial.

Eighty-one of 84 (96 percent) receiving buprenorphine implants and 78 of 89 (88 percent) receiving sublingual buprenorphine were responders (? 4 of 6 months without opioid-positive urine test result [monthly and 4 times randomly] and self-report). Over 6 months, 72 of 84 (86 percent) receiving buprenorphine implants and 64 of 89 (72 percent) receiving sublingual buprenorphine maintained opioid abstinence. Non-implant-related and implant-related adverse events occurred in 48 percent and 23 percent of the buprenorphine implant group and in 53 percent and 13.5 percent of participants in the sublingual buprenorphine group, respectively.

"Buprenorphine is an effective treatment for opioid dependence; however, adherence to daily dosing for management of chronic disorders is challenging. An implantable buprenorphine delivery system reduces adherence issues and may improve efficacy," the authors write.

"Among adults with opioid dependence maintaining abstinence with a stable dose of sublingual buprenorphine, the use of buprenorphine implants compared with continued sublingual buprenorphine did not result in an inferior likelihood of remaining a responder. However, the study population had an exceptionally high response rate in the control group, and further studies are needed in broader populations to assess the efficacy in other settings."

(doi:10.1001/jama.2016.9382; the study is available pre-embargo at the For the Media website)

Editor's Note: This study was funded by Braeburn Pharmaceuticals. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, etc.

Editorial: Improving Outcomes for Persons With Opioid Use Disorders

"This novel implant system may help buttress patients' decision-making deficits that are a core component of the addiction by making these lifesaving medication adherence decisions far more infrequent," write Wilson M. Compton, M.D., M.P.E., and Nora D. Volkow, M.D., of the National Institute on Drug Abuse, Bethesda, Md., in an accompanying editorial.

"However, buprenorphine implants are currently approved by the U.S. Food and Drug Administration for only up to 1 year of treatment for a subgroup of patients who have already achieved and sustained prolonged clinical stability while receiving low to moderate doses of oral transmucosal buprenorphine, a caveat clearly stated in the product label. Even so, this novel approach to delivering care may open up treatment for new, previously difficult-to-reach populations or for those in the criminal justice system. Although further research is needed to determine which populations would benefit the most from these new formulations, the potential of these agents to have a positive role in the current opioid crisis is undeniable."

(doi:10.1001/jama.2016.8897; the editorial is available pre-embargo at the For the Media website)

Editor's Note: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr. Compton reports stock ownership in Pfizer, General Electric, and 3M. No other disclosures were reported.

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Media Advisory: To contact Richard N. Rosenthal, M.D., email Sasha Walek at sasha.walek@mountsinai.org. To contact editorial co-author Wilson M. Compton, M.D., M.P.E., email media@nida.nih.gov.

To place an electronic embedded link to this study and editorial in your story These links will be live at the embargo time: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.9382 http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.8897

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