The Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee.
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.
ISS has almost two decades of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact email@example.com
Do you have an upcoming Advisory Committee Meeting?
Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more
FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Read more
One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more
US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more
The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us todayContact us