Phase III trial of CAM 2038 (buprenorphine depots) shows positive results in moderate-to-severe opioid use disorder- Camurus and Braeburn Pharmaceuticals

Camurus and Braeburn Pharmaceuticals announced positive top-line results from a long-term Phase III trial supporting the safety and efficacy of CAM 2038 (weekly and monthly buprenorphine depots) in patients with moderate-to-severe opioid use disorder. 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. Importantly, as in the previous Phase 3 efficacy study, no opioid overdoses were reported for patients treated with CAM2038 depot injections.

Overall, headache, nausea, vomiting, nasopharyngitis, and urinary tract infection were the most common adverse events; in each case reported by less than 10% of patients. Injection site reactions occurred in 20% of the participants and were generally mild (16.3%) or moderate (3.5%). Severe injection site pain was reported for one patient (0.4%). Notably, more than 5000 injections of CAM2038 were administered in the study. 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.