Braeburn — Brixadi FDA Review (NDA210136, ORIG 1, 2023)
Braeburn · 2023 · FDA Review (openFDA)
Report summary
The FDA reviewed Braeburn Pharmaceuticals' NDA for Brixadi (CAM2038), an extended-release buprenorphine injection for opioid use disorder (OUD). Despite initial regulatory challenges, including a Complete Response letter due to manufacturing and data quality issues, the application was resubmitted. The pivotal Study HS-11-421 demonstrated CAM2038's non-inferiority to sublingual buprenorphine/naloxone. The clinical program, including Phase 2 and 3 studies, confirmed an efficacy and safety profile consistent with known buprenorphine effects, with injection-site reactions being the primary exception. The advisory committee recommended approval for both weekly and monthly formulations, leading to a favorable risk-benefit assessment and a recommendation for approval, alongside a REMS program for safe use.
Key findings — cited to the page
| Injection site irritation (SL BPN/NX) | <1 % | Study 421 · p.93 |
| NDA 210136 Complete Response Date | January 19, 2018 | Brixadi (CAM2038) · p.11 |
| Priority Status | Priority | Brixadi (CAM2038) · p.2 |
| Number of enrolled patients in HS-11-421 | 428 | HS-11-421 · p.23 |
| Application Number | 210136 | Brixadi (CAM2038) · p.2 |
| Application Type | NDA | Brixadi (CAM2038) · p.2 |
| Recommended Regulatory Action | Approval | Brixadi (CAM2038) · p.2 |
| Submit Date | June 26, 2018 | Brixadi (CAM2038) · p.2 |
| Received Date | June 26, 2018 | Brixadi (CAM2038) · p.2 |
| PDUFA Goal Date | December 26, 2018 | Brixadi (CAM2038) · p.2 |
| Review Completion Date | 11/30/2018 | Brixadi (CAM2038) · p.2 |
| Proposed Indication | For the treatment of moderate to severe opioid use disorder in patients who have tolerated at least a test dose of a 4 mg transmucosal buprenorphine product. | Brixadi (CAM2038) · p.2 |
Source: Braeburn ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →