Phase III efficacy study of CAM 2038 meets endpoints in chronic low back pain.- Camurus.

Camurus announced positive results from a Phase III efficacy study of CAM 2038, weekly and monthly buprenorphine depots, in opioid experienced patients with chronic low-back pain. The study successfully met its primary and first secondary endpoints by demonstrating that treatment with CAM 2038 resulted in significantly improved relief of the average and worst pain intensity compared to placebo. The additional secondary endpoints were supportive of the main results. The primary and key secondary efficacy endpoints of the study were the change in means of the average and worst pain intensity from baseline (week of randomization) to week 12 (last week of the randomized phase). The treatment difference for CAM 2038 versus placebo was 1.03 for the average pain intensity and 1.11 for the worst pain intensity.

The overall safety profile of CAM 2038 in chronic pain patients was favorable and generally consistent with earlier studies in patients with opioid dependence and the known safety profile of buprenorphine. Following completion of the randomized efficacy part of the Phase III study, the long-term safety of CAM 2038 is being evaluated in a 52-week open label extension study, in which patients either are continuing from the randomized efficacy part of the study or are included directly in the open label extension study phase.

Comment: Chronic pain represents a major healthcare problem despite advances in pharmacotherapy, invasive and non-invasive interventions. The prevalence of chronic pain in Europe and the US is close to 20% and the individual and societal costs associated with chronic pain are significant. Chronic pain has a complex etiology and those affected frequently have medical and psychiatric co-morbidities such as depression, anxiety, and drug dependence. Patients afflicted with both pain and opioid dependence are often particularly challenging to treat.