Braeburn President and CEO, Mike Derkacz shared the Company’s commitment to expanding opioid use disorder (OUD) treatment options through cutting edge research and improving access to Medication Assisted Therapy (MAT), in alignment with the HHS five-point strategy to reverse the trajectory of the epidemic.
“The goals of Braeburn are closely aligned with the priorities stated by HHS and we are working diligently to create new treatment options for patients and healthcare providers desperately in need of individualized solutions — from initiation and stabilization, to longer-term maintenance therapy,” said Mike Derkacz, President and CEO of Braeburn. “The opioid epidemic is a complex and devastating problem facing Americans, and Braeburn is honored to be partnering with HHS and other industry leaders to help provide solutions for people living with the serious, often fatal consequences of opioid addiction.”
The Company’s CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder, was accepted under Priority Review designation by the Food and Drug Administration in September 2017 and previously granted Fast Track designation. Additionally, the FDA has recently published notice via the Federal Register, that a joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will review Braeburn’s New Drug Application for CAM2038 on November 1, 2017.
Braeburn also participated in the September 27 Meeting of the President’s Commission on Combating Drug Addiction and the Opioid Crisis.
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 www.braeburnpharmaceuticals.com.
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