Additional Relevant Details
The primary efficacy endpoint was the proportion of responders, defined as participants with at least four of six months without evidence of illicit opioid use by urine test and by self-report. As previously reported, the study met its primary endpoint as well as all secondary endpoints, and the treatment was well tolerated by the study subjects. Post-hoc sensitivity analyses of responder rates were performed to further test the pre-specified endpoints and primary analysis detailed in the Statistical Analysis Plan provided to the FDA. Additional details are included in the poster presentation, which was co-authored by Richard N. Rosenthal, MD, Professor of Psychiatry and Medical Director of Addiction Psychiatry at the Icahn School of Medicine at Mount Sinai; Michelle R. Lofwall, M.D., University of Kentucky College of Medicine, Center on Drug and Alcohol Research in Lexington, Kentucky; Sonnie Kim, Ph.D., Braeburn Pharmaceuticals; Katherine L. Beebe, Ph.D., Titan Pharmaceuticals; Michael Chen, Ph.D., TCM Groups, Inc.; and Frank J. Vocci, Ph.D., Friends Research Institute.


"These post hoc sensitivity analyses showed that even under the most conservative method, the Probuphine long-acting subdermal implant demonstrated efficacy in direct comparison with sublingual buprenorphine," said co-lead investigator and an author of the presentation Richard N. Rosenthal, M.D., Professor of Psychiatry and Medical Director of Addiction Psychiatry at the Icahn School of Medicine at Mount Sinai. "Importantly, the analyses also supported previous findings that participants treated with the Probuphine implant were more likely to remain free of illicit opioids compared with those on sublingual buprenorphine. These results hold great promise for Probuphine as a new option for clinicians and patients seeking greater access to medications for the maintenance treatment of opioid addiction."