PRINCETON, N.J., Sept. 27, 2017 /PRNewswire/ -- Braeburn Pharmaceuticals, Inc. (Braeburn) today participated in the Third Meeting of the President's Commission on Combating Drug Addiction and the Opioid Crisis held in the Eisenhower Executive Office of the President in Washington, DC. Braeburn President and CEO, Mike Derkacz shared the Company's progress in advancing new, long-acting treatment options to help address the escalating disease burden of addiction faced by Americans, including the development of injectable treatments for opioid use disorder (OUD) to potentially minimize the risk of diversion and abuse.
"Braeburn is fully committed to working with the Commission, healthcare professionals, lawmakers, payers and regulators to deliver solutions for people living with the serious, often fatal consequences of opioid addiction," said Mike Derkacz, President and CEO of Braeburn. "We believe that people who suffer from addiction and the healthcare professionals who treat them will greatly benefit from the expansion of treatment options and improved access to medication-assisted therapy. Until we make it as easy to get treatment as it is to get illicit drugs in this country, the epidemic will continue."
In 2016, roughly 10.6 million adults misused opioids in the US and only 1.2 million of them were treated, according to the Substance Abuse and Mental Health Services Administration (SAMHSA). According to the NIH, 25 million Americans suffer from daily chronic pain. FDA Commissioner Scott Gottlieb has referred to medication-assisted therapy as "one of the major pillars of the federal response to the opioid epidemic in this country."
"Braeburn announced last week that the New Drug Application for CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder, was accepted under Priority Review and granted Fast Track designation by the FDA, accelerating the timeline for which CAM2038, if approved, will provide new options for patients struggling with opioid use disorder," said Sonnie Kim, Pharm.D., Chief Scientific Officer at Braeburn. "These treatments, if approved, will be administered by healthcare professionals to ensure proper delivery and medication adherence, while potentially minimizing risks of diversion, misuse and accidental pediatric exposure."
This third Commission meeting was livestreamed and is available at WhiteHouse.gov: https://www.whitehouse.gov/live.
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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