CAM2038

CAM2038 is a drug for which a New Drug Application (NDA 210136) was submitted on June 26, 2018, and received Priority status. The regulatory review concluded with a recommendation for Approval on November 30, 2018, with a PDUFA Goal Date of December 26, 2018.

Efficacy studies demonstrated non-inferiority of CAM2038 compared to sublingual buprenorphine/naloxone (SL BPN/NX) in response rate (p = 0.001), with a non-inferiority margin of 10%. This non-inferiority was achieved in Study 421, which enrolled 213 patients for CAM2038 and 428 total patients. Opioid blockade was observed in Study 478 (47 patients), where CAM2038 blocked the subjective effects of both 6 mg and 18 mg doses of hydromorphone. Superiority of CAM2038 to SL BPN/NX was not demonstrated.

Safety findings indicate that systemic effects of buprenorphine associated with CAM2038 occurred in ≥ 2% of patients and included headache, nausea, constipation, vomiting, elevated liver enzymes, sedation, and somnolence. Common injection site reactions included pain, pruritus, and erythema. Treatment-emergent adverse events leading to drug discontinuation were ≤ 5%. In Study 421, 6 patients in the CAM2038 group discontinued due to adverse events, compared to 1 patient in the SL BPN/NX group. One death occurred in the CAM2038 group in Study 421.