Princeton, N.J.—January 21, 2018 — Braeburn Pharmaceuticals, Inc. (Braeburn) today announced that it has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the new drug application (NDA) for CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder (OUD). The FDA has requested additional information in order to progress the application forward. There is no need for additional clinical studies and the Agency’s requests will be addressed in a timely manner.
“Braeburn will continue to work closely with the FDA with the goal of bringing CAM2038 to market as quickly as possible,” said Mike Derkacz, President and CEO of Braeburn. “Opioid addiction is one of the worst public health crises in our nation’s history. We are committed to introducing this innovative treatment to better meet the overwhelming needs of patients.”
CAM2038 was previously granted Fast Track and Priority Review designations by the FDA. If approved, CAM2038 would be the first and only injectable for OUD that can be administered by healthcare professionals from Day 1 of a patient’s OUD treatment.
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 the U.S.. 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.”
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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