CAM 2038 is resubmitted by Braeburn Pharma to the FDA for the treatment of opioid use disorder.

Braeburn announces the resubmission of the New Drug Application (NDA) for CAM 2038, an investigational buprenorphine flexible-dose weekly and monthly depot injection for the treatment of opioid use disorder (OUD). The resubmission is in response to the Complete Response Letter issued by the FDA in January requesting additional information without the need for further clinical studies.

The NDA is supported by comprehensive evidence from seven clinical trials, five of which are in patients with OUD, including two Phase III studies. The pivotal Phase III efficacy and safety study demonstrated non-inferiority of CAM 2038 versus treatment with the current standard of care, sublingual buprenorphine/naloxone, for the primary endpoint of responder rate as well as superiority for the proportions of negative urine toxicology for illicit opioids. Further, CAM 2038 evidenced long-term safety and tolerability in the second Phase III safety study. Braeburn expects to receive an action date within 30 days of submission.