Global utilization trends for weekly/monthly injectable buprenorphine (CAM2038) in the treatment of Opioid Use Disorder

Background 

Opioid Use Disorder (OUD) is a global health crisis. Opioids make up 69% of overdose deaths worldwide. Estimates of people using opioids globally doubled from 26-36 million in 2010 to ~61.3 million in 2020. The current opioid epidemic experience varies globally due to geographic differences in the prevalence of illicit opioid types. In Africa, Middle East and parts of Asia, tramadol use is widespread, and in North America, overdose deaths are driven by high-potency synthetic opioids (HPSO). Buprenorphine (BPN) for OUD treatment has strong evidence with decades of use and is a World Health Organization listed essential medicine. BPN treatment delivery is via various models of care worldwide with significant regional differences. CAM2038 is an extended-release BPN available in multiple doses in weekly (8 mg, 16 mg, 24 mg 32 mg) and monthly (64 mg, 96 mg, 128 mg, and 160 mg [available ex-US only]) formulations, allowing for flexible dosing to address individual patient needs. Efficacy was observed across all CAM2038 doses in controlled studies. CAM2038 has been authorized since 2018 in Europe, 2019 in Australia, 2022 in the Middle East and North Africa (MENA), and 2023 in the United States (US).  US guidelines emphasize individualized dosing and visit frequency to clinical response.  Some suggest that higher BPN doses are favored in the context of HPSO, but utilization in real-world settings is unknown.

Methods 

The proportion of each dose dispensed, calculated from pooled 2023 data from Middle Eastern and North African countries, Australia and Europe (Sweden, Demark, Finland, Norway, Germany, Austria, United Kingdom, Spain, France, Ireland, Iceland, Slovenia, Belgium, Ukraine, Italy) is compared to data from the US from launch (Sept. 5, 2023) to Dec. 31, 2023.

Results

Pooled ex-US data (MENA, Australia, Europe) demonstrates all CAM2038 doses were utilized for both weekly (8mg: 7%, 16mg: 9%, 24mg: 12%, 32mg: 14%) and monthly (64mg: 13%, 96mg: 18%, 128mg: 19%, 160mg: 8%) formulations. Similarly, US data demonstrates all doses were utilized for CAM2038 weekly (8mg: 6%, 16mg: 11%, 24mg: 23%, 32mg: 9%) and monthly (64mg: 10%, 96mg: 22%, 128mg: 18%).

Conclusion

Global introduction of CAM2038 for the treatment of OUD has expanded the spectrum of available long-acting BPN to include various dose strengths and weekly and monthly options. CAM2038 8mg is typically used for titration or supplementation, and CAM2038 16mg is usually used as a starting dose in new to treatment individuals, likely accounting for less utilization than other doses. Except for CAM2038 160mg, which is not available in the U.S., dose utilization trends are similar between U.S and ex-US, regardless of regulatory differences. Despite concerns about HPSO in the U.S., higher doses of CAM2038 do not appear to be preferred over other doses. While local regulations may play a role in certain utilization patterns, this data supports that individualization of treatment occurs globally.