Braeburn Announces FDA Advisory Committee Recommends Approval of CAM2038 Buprenorphine Depot for the Treatment of Opioid Use Disorder

Recommendation based on review of clinical data comprising a broad, real-world opioid use disorder (OUD) population including patients who had concomitant use of other non-opioid substances of abuse

A New Drug Application (NDA) for CAM2038 is under FDA priority review with a Prescription Drug User Fee Act (PDUFA) target date of January 19, 2018

Additionally, Braeburn welcomes today’s final report from the President’s Commission on Combating Drug Addiction and the Opioid Crisis

Princeton, N.J.—November 1, 2017 — Braeburn Pharmaceuticals, Inc. (Braeburn) today announced that the U.S. Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee jointly voted 17-3 recommending approval of CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder (OUD).

“The panel’s recommendation in favor of CAM2038 brings us another step closer to providing an individualized treatment option to support OUD patients from day one of their recovery, through initiation, to longer-term maintenance therapy,” said Mike Derkacz, President and CEO of Braeburn. “The magnitude of the opioid crisis noted in the President’s Commission report today reinforces the need for new, medication assisted therapies such as CAM2038, which is administered by healthcare professionals ensuring medication adherence, while potentially minimizing risks of diversion, abuse, misuse, and accidental pediatric exposure.”

The FDA asked the Committees to vote on recommended approval of all, some or none of the proposed doses of CAM2038. 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.

In 2016, roughly 11.6 million adults misused opioids in the U.S. yet only 1.1 million received medication assisted therapy (MAT), according to the Substance Abuse and Mental Health Services Administration (SAMHSA). Opioid overdose is now the leading cause of death among people under the age of 50 in this country. Today’s White House Commission report outlined the critical need for MAT in treating opioid addiction, and called for increased funding for opioid addiction related activities.

The Advisory Committee’s recommendation 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. CAM2038 was accepted under Priority Review designation by the FDA in September 2017 and previously granted Fast Track designation. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of January 19, 2018.

About CAM2038

CAM2038 is an investigational buprenorphine weekly and monthly depot subcutaneous injection for the treatment of opioid use disorder, as a part of a comprehensive treatment plan to include counseling and psychosocial support. The product is designed for flexible and individualized treatment from initiation and stabilization to longer-term maintenance therapy, providing sustained buprenorphine release in once weekly and once monthly formulations. Administration by healthcare professionals ensures delivery and medication adherence, while potentially minimizing risks of diversion, misuse, and accidental pediatric exposure. CAM2038 has been successfully evaluated in seven Phase 1-3 clinical trials, including a pivotal Phase 3 efficacy and a long-term safety study. The safety profile of CAM2038 was generally consistent with the known safety profile of buprenorphine, with the exception of mild-to-moderate injection-site adverse events.

CAM2038 is presented ready for use in prefilled syringes for weekly or monthly administration by a healthcare professional. If approved, CAM2038 will be offered in dosage strengths for once weekly (8 mg to 32 mg) and once monthly (64 mg to 160 mg) subcutaneous injections.

About Braeburn Pharmaceuticals

Braeburn is a pharmaceutical company dedicated to delivering solutions for people living with the serious, often fatal consequences of opioid addiction. The company’s mission is to advance a portfolio of next-generation therapies, with individualized dosing regimens and delivery options, to address the escalating disease burden of addiction faced by patients, healthcare professionals, payers and society. For more information about Braeburn, please visit https://braeburnrx.com.

For additional information, please contact:

Media Relations:
Nancy Leone: nleone@braeburnpharma.com

Investor Relations:
Chris Taylor: ctaylor@braeburnpharma.com