Braeburn Inc.: BRIXADI

Please refer to your new drug application (NDA) dated and received July 19, 2017, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for BRIXADI (buprenorphine) extended-release injection for subcutaneous use.

We acknowledge the submission of your proposed modified REMS on July 6, 2021, which contains a Medication Guide, elements to assure safe use, an implementation system and a timetable for submission of assessments of the REMS.

July 6, 2021; and the REMS Supporting Document and REMS Assessment Plan submitted on October 22, 2021, and amended December 1, 2021. We will make a final decision on your proposed modified REMS after your complete response to this action letter has been submitted.

The recommendation to evaluate elemental impurities, as noted in the tentative approval letter dated December 21, 2018, may be submitted as a postmarketing requirement.

Food, Drug, and Cosmetic Act (FDCA) for BRIXADI (buprenorphine) extended-release injection for subcutaneous use.

During a recent inspection for this application of the Pharmaceutics International |"

Satisfactory resolution of these deficiencies is required before this application may be approved.

We acknowledge the submission of your proposed modified REMS on June 1, 2020, which contains a Medication Guide, elements to assure safe use, an implementation system and a timetable for submission of assessments of the REMS.

1. Postmarketing clinical trial exploring how BRIXADI can be safely initiated at doses of 24 mg to 32 mg BRIXADI (weekly) without titration.

The goals of the trial are to determine an accelerated dose-initiation regimen using BRIXADI (weekly) and assess the associated risks of precipitated withdrawal or inadequate dosing.

Any additional specific details of this required postmarketing study, including a timetable and annual reporting requirements, will be described more fully in the approval letter for this application, if it is approved.

If you complete this study prior to re-submitting your application, you may include the final report and relevant data sets in your Complete Response submission to facilitate review of the information.

Therefore, no additional data are required, but the findings must be included in labeling.