Brixadi(buprenorphine extended-release)

Psychiatry· 211 cited findings· 1 source document

Company: Braeburn

What the regulatory reviews say

Brixadi (buprenorphine extended-release) is a medication for which a New Drug Application (NDA 210-136) was submitted on June 26, 2018, with a PDUFA date of December 26, 2018. The review priority was classified as a Class II Resubmission. The IND number associated with this drug is 114,082.

In efficacy trials, the responder rate for Brixadi (CAM2038) was 16.9%, compared to 13.9% for sublingual buprenorphine/naloxone (SL BPN/NX). The responder rate difference between CAM2038 and SL BPN/NX was 2.9%, with a 95% confidence interval ranging from -3.9% to 9.8%. Non-inferiority was demonstrated with a P-value of < 0.001. The mean percentage of urine samples negative for illicit opioids over Weeks 5-25 was 35.1% for CAM2038, compared to 26.7% for SL BPN/NX, with a Wilcoxon Rank Sum Test P-value of 0.004.

Regarding safety, no new hepatic safety concerns were identified. The adverse event discontinuation rate in the CAM2038 arm was 0.5%, which was the same as in the SL BPN/NX arm. The rate of injection site reactions was 18.8%.

Key figures — cited to the source page

Responder rate (CAM2038)	16.9%	Braeburn — Brixadi FDA Review, p.10
Responder rate (SL BPN/NX)	13.9%	Braeburn — Brixadi FDA Review, p.10
Responder rate difference (CAM2038 vs SL BPN/NX)	2.9%	Braeburn — Brixadi FDA Review, p.10
Non-inferiority P-value	< 0.001	Braeburn — Brixadi FDA Review, p.10
Mean percentage of urine samples negative for illicit opioids (CAM2038, Weeks 5-25)	35.1	Braeburn — Brixadi FDA Review, p.12
Mean percentage of urine samples negative for illicit opioids (SL BPN/NX, Weeks 5-25)	26.7	Braeburn — Brixadi FDA Review, p.12
Injection site reactions rate	18.8%	Braeburn — Brixadi FDA Review, p.21
NDA number	210-136	Braeburn — Brixadi FDA Review, p.2

Source documents

Braeburn — Brixadi FDA Review (NDA210136, ORIG 1, 2023) (2023)

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.