(266) Dosing to effect with weekly and monthly subcutaneous buprenorphine: post-hoc analysis of a Phase 3, open-label study

Background: : The safety and effectiveness of buprenorphine (BPN) in various formulations has been established for the treatment of patients with opioid use disorder (OUD). Clinical practice guidelines indicate that the dose and frequency of BPN should be individualized to patients’ treatment needs. CAM2038 is an extended-release injectable BPN available in weekly and monthly formulations with multiple doses.

Objective: : A post-hoc analysis was conducted to evaluate the impact of CAM2038 dose on OUD treatment outcomes in a 48-week, open-label, flexible-dosing, multi-national Phase 3 study evaluating the long-term safety, tolerability, and efficacy of CAM2038 in adults with moderate to severe OUD.

Methods: : Participants new to treatment at baseline were initiated with CAM2038 weekly and participants on sublingual (SL) BPN treatment were transitioned to CAM2038 weekly or monthly at doses corresponding to their prior daily treatment. The study included flexible CAM2038 doses and individualized dose adjustments were permitted at any time during the treatment phase. Urine samples were collected at weekly or monthly visits based on the frequency of CAM2038 injections. The mean percentage of urine samples negative for illicit opioids was evaluated for each dose received (the dose associated with the outcome was the last dose received prior to collection of the urine sample). Supplemental BPN doses were not included, and missing values were not imputed.

Results: : In participants converted from SL BPN, all available CAM2038 doses were utilized during the study, however, the majority received 24 mg or 32 mg CAM2038 weekly and 96 mg or 128 mg CAM2038 monthly. In new-to-treatment participants, the majority received 24 mg of CAM2038 weekly and 96 mg CAM2038 monthly. For participants converted from SL BPN and new to treatment, the mean percentage of urine samples negative for illicit opioids was similar across weekly doses of 16 mg, 24 mg, and 32 mg and all monthly doses of CAM2038. Across all doses, opioid withdrawal and cravings were similar and well-controlled.

Conclusions: : Participants responded to all doses of CAM2038 and all doses were generally well-tolerated. Treatment with CAM2038, administered at individualized doses based on clinical response, resulted in positive outcomes for OUD. As these are post-hoc analyses, more research is needed to evaluate the impact of CAM2038 dose on OUD treatment outcomes.

Sponsorship:: Braeburn Inc.