FDA
25th November 2017

FDA Advisory Committee Recommends Approval of Two Buprenorphine Products for the Treatment of Opioid Use Disorder

The Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee.

FDA Advisory Committee Recommends Approval of Two Buprenorphine Products for the Treatment of Opioid Use Disorder

The Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) convened on October 31st and November 1st to discuss two buprenorphine subcutaneous injections for treatment of opioid dependence.

On October 31st the joint committee discussed buprenorphine subcutaneous injection (RBP-600; NDA 209819), submitted by Indivior Pharmaceuticals, Inc. and on the following day, the committees discussed the buprenorphine subcutaneous injection (CAM2038; NDA 210136), submitted by Braeburn Pharmaceuticals, Inc. Both products received a positive vote in favor of approval for the treatment of opioid dependence.

Indivior’s RBP-6000, is a once-monthly injectable buprenorphine formulation in the ATRIGEL® delivery system for the treatment of adults with moderate-to-severe opioid use disorder (OUD), as part of a complete treatment plan including counseling and psychosocial support. RBP-600 consists of a polymeric solution of a biodegradable poly-(DL-lactide-co-glycolide) co-polymer dissolved in N-methyl pyrrolidone (NMP), a water-miscible biocompatible solvent. After subcutaneous injection, NMP diffuses out of the polymer matrix and the polymer precipitates, trapping buprenorphine inside and forming an amorphous solid depot in situ. The depot releases buprenorphine over a one-month period by diffusion as the polymer biodegrades. The committees jointly voted 18 to 1 in support of the approval of RBP-6000 for the treatment of OUD. The one committee member who voted “No” felt that there was a disconnect between the realities of how buprenorphine is used in the real-world and that the data presented did not support clinical use. The FDA has set a target action date of November 30th, 2017 for RBP-6000.

Braeburn’s CAM2038 is a weekly and monthly buprenorphine subcutaneous injection for the treatment of OUD, as a part of a comprehensive treatment plan to include counseling and psychosocial support.  The committees voted 17-3 recommending approval of CAM2038.The FDA asked the committees to vote on recommended approval of all, some or none of the proposed doses of CAM2038. The proposed doses were as follows: Weekly formulations for OUD treatment including 8, 16, 24, and 32 mg, which deliver 0.16, 0.32, 0.48, and 0.64 mL of buprenorphine respectively; or monthly formulations for OUD treatment including 64, 96, 128, and 160 mg which deliver 0.18, 0.27, 0.36, and 0.45 mL of buprenorphine, respectively.

The Committees voted 17 in favor of approval of some of the proposed doses and 3 in favor of none of the proposed doses of CAM2038. The majority of the committee had concerns about the lack of data for the higher doses. Those committee members voting against all the proposed doses, felt that more long-term data is needed to support safety.  The recommendation for approval was based on a review of results from a clinical trial program that included seven Phase 1-3 clinical trials in patients with OUD, including a pivotal Phase 3 efficacy and a long-term safety study. The clinical data comprised of a broad, real-world patient population including patients who had concomitant use of other non-opioid substances of abuse. The NDA for CAM2038 is under FDA priority review with a target action date of January 19th, 2018.

FDA advisory committees are panels of independent experts who advise the FDA on specific questions raised by the FDA as they consider regulatory decisions. The FDA is not obligated to follow the advice of the committee, but normally does so.

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