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 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. Additionally, 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.
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CAM2038 is an investigational buprenorphine weekly and monthly depot subcutaneous injection for the treatment of opioid use disorder, as a part of a comprehensive treatment plan to include counseling and psychosocial support. The product is designed for flexible and individualized treatment from initiation and stabilization to longer-term maintenance therapy, providing sustained buprenorphine release in once weekly and once monthly regimens. Administration by healthcare professionals ensures delivery and medication adherence, while potentially minimizing risks of diversion, misuse, and accidental pediatric exposure. In November 2017, the U.S. Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee jointly voted 17-3 for recommending approval of CAM2038. The Advisory Committee's recommendation was based on a review of results from a clinical trial program that included seven Phase 1-3 clinical trials, five of which were in patients with OUD, including a pivotal Phase 3 efficacy and Phase 3 long-term safety study. The safety profile of CAM2038 was generally consistent with the known safety profile of buprenorphine, with the exception of mild-to-moderate injection-site adverse reactions.
CAM2038 is presented ready for use in prefilled syringes for weekly or monthly administration by a healthcare professional. If approved, CAM2038 will be offered in a range of dosage strengths for once weekly and once monthly subcutaneous injections.