Camurus and Braeburn Pharmaceuticals announced positive top-line results from a long-term Phase 3 trial supporting the safety and efficacy of CAM2038 (weekly and monthly buprenorphine depots) in patients with moderate-to-severe opioid use disorder.
"These new Phase 3 results add to the growing body of evidence supporting the use of our weekly and monthly buprenorphine depots (CAM2038) as a flexible, individualized therapy for patients with opioid use disorder," Fredrik Tiberg, President & CEO, Camurus said. "The present long-term study confirms the safety profile and efficacy of CAM2038 in both new-to-treatment patients and patients on maintenance treatment with daily buprenorphine. The results further strengthen our upcoming regulatory submissions to EMA and FDA in mid-2017."
A total of 228 patients were enrolled in the study conducted at 29 sites across the U.S., Europe and Australia; 162 (71%) patients completed the 48-week study treatment period. The safety profile of CAM2038 was similar to that observed in previous shorter term trials. A total of 17 (7%) serious adverse events were reported in this 48-week study (52 weeks including follow-up), of which none was considered related to the study medication. As in the previous Phase 3 efficacy study, no opioid overdoses were reported for patients treated with CAM2038 depot injections.
Efficacy was assessed by weekly and monthly urine toxicology tests. On average, 75% of the urine samples were negative for illicit opioids across the 48-week treatment period.