Braeburn — Brixadi FDA Review (NDA210136, ORIG 1, 2023)
Braeburn · 2023 · FDA Review (openFDA)
Report summary
The FDA statistical review of Braeburn's Brixadi (CAM2038) for opioid use disorder confirmed its non-inferiority to sublingual buprenorphine/naloxone in responder rate, supporting approval. While data quality issues were identified and corrected, they did not alter the primary efficacy conclusions. The safety evaluation found no new hepatic concerns. Efficacy subgroup analyses showed no notable differences across demographics (sex, race, age), but variations were observed based on the primary opioid of use and route of illicit opioid use. The report also explored negative urine samples for illicit opioids, but dose-response effects could not be determined.
Key findings — cited to the page
| Responder rate difference (CAM2038 vs SL BPN/NX) | 2.9% | · p.10 |
| Non-inferiority P-value | < 0.001 | · p.10 |
| NDA submission date | June 26, 2018 | · p.2 |
| Responder rate | 13.9% | SL BPN/NX · p.10 |
| Responder rate difference (CAM2038 vs SL BPN/NX) 95% CI lower bound | -3.9% | · p.10 |
| Responder rate difference (CAM2038 vs SL BPN/NX) 95% CI upper bound | 9.8% | · p.10 |
| PDUFA date | December 26, 2018 | Brixadi (CAM2038) · p.2 |
| Review Priority | Class II Resubmission | · p.2 |
| NDA submission date | June 26, 2018 | · p.5 |
| Responder rate | 16.9% | CAM2038 · p.10 |
| NDA number | 210-136 | Brixadi (CAM2038) · p.2 |
| Responder rate (indeterminate results classified as positive) | 15.5% | CAM2038 · p.10 |
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 →