Sensitivity analyses confirm efficacy of long-acting buprenorphine implant for opioid dependence

Findings presented at the College on Problems of Drug Dependence annual meeting further supported previously reported efficacy of Probuphine, a 6-month subdermal buprenorphine implant recently approved for the maintenance and treatment of opioid dependence.

“This study further demonstrated the robustness of the data in the pre-specified analysis provided to the FDA, and we are pleased to be presenting the results at this scientific meeting,” Kate Beebe, PhD, executive vice president and chief development officer of Titan Pharmaceuticals, said in a press release.

Phase 3 study results recently presented at the American Society of Addiction Medicine annual conference indicated efficacy of Probuphine for long-term maintenance treatment of opioid addiction.

Adults with opioid dependence (n = 177) who were clinically stabilized for at least 3 months on 8 mg or more of sublingual buprenorphine were randomly assigned to receive daily sublingual buprenorphine tablets at their previous maintenance dose and four placebo implants or daily sublingual buprenorphine tablets plus four long-acting buprenorphine implants.

The intent-to-treat population included 173 participants, of which 84 received long-acting buprenorphine implants. Following implantation, participants provided urine samples at six scheduled monthly visits and four randomly assigned visits.

Researchers conducted post-hoc analyses among the intent-to-treat population to further support efficacy findings, which included additional multiple sensitivity analyses using stringent parameters that disfavored the buprenorphine implant cohort.

Analyses involving participants using supplemental buprenorphine as nonresponders (P = .495), all missing urine samples attributed as positive (P = .393), and supplemental buprenorphine use attributed nonresponders and missing urine samples attributed as positive (P = .926) indicated buprenorphine implants were noninferior to daily sublingual buprenorphine tablets.

“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,” Richard N. Rosenthal, MD, of the Icahn School of Medicine at Mount Sinai, said in the release. “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.” – by Amanda Oldt

Reference:

Rosenthal R, et al. Sensitivity analysis of a comparative trial of 6-month buprenorphine implants (Probuphine) and sublingual buprenorphine in stable opioid-dependent patients. Presented at: The College on Problems of Drug Dependence Annual Meeting; June 11-16, 2016; Palm Springs, Calif.

Disclosure: The study was supported by Braeburn Pharmaceuticals.