Braeburn announces the resubmission of the New Drug Application (NDA) for CAM2038, 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 U.S. Food and Drug Administration in January requesting additional information without the need for further clinical studies.
“The unmet need for patients and healthcare providers dealing with opioid use disorder is escalating,” said Mike Derkacz, President and CEO of Braeburn, “and Braeburn is fully committed to providing a therapy to support patients throughout their recovery journey.”
The NDA is supported by comprehensive evidence from seven clinical trials, five of which are in patients with OUD, including two Phase 3 studies. The pivotal Phase 3 efficacy and safety study demonstrated non-inferiority of CAM2038 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, CAM2038 evidenced long-term safety and tolerability in the second Phase 3 safety study. Braeburn expects to receive an action date within 30 days of submission.