16 Jul Braeburn Announces PDUFA Date for CAM2038 for the Treatment of Opioid Use Disorder
If approved, CAM2038 will provide patients and HCPs with flexible-dose weekly and monthly options for the treatment of opioid use disorder, with the goal of improving treatment adherence and reducing the burdens associated with daily medication.
Plymouth Meeting, Pa. —July 16, 2018 —Braeburn announces that the U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2018 for its New Drug Application (NDA) for CAM2038, an investigational buprenorphine flexible-dose weekly and monthly subcutaneous depot injection for the treatment of adults with opioid use disorder (OUD). CAM2038 was previously granted Fast Track and Priority Review designations.
“CAM2038 is a potentially game-changing treatment for patients with OUD,” said Mike Derkacz, President and CEO of Braeburn. “CAM2038 weekly and monthly provide a range of doses that align with the varying needs of patients and will be administered by a healthcare professional.”
If approved, CAM2038 would be the first and only injectable for OUD available in both weekly and monthly formulations that can be administered by healthcare professionals through all stages of a patient’s recovery journey. CAM2038 is designed to permit “dose matching” to existing oral buprenorphine formulations and enables immediate treatment initiation with a depot injection without the need to complete an oral dose adjustment phase. Braeburn will continue to work closely with the FDA to advance the NDA for CAM2038 and help confront the worst public health crisis in the United States.
CAM2038 is an investigational buprenorphine weekly and monthly depot subcutaneous injection for the treatment of opioid use disorder, to be used 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 helps to ensure delivery and medication adherence, while potentially minimizing risks of diversion, misuse, and accidental pediatric exposure.
In November 2017, the U.S. Food and Drug Administration’s Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee jointly voted 17-3 for recommending approval of CAM2038. The Advisory Committee’s recommendation was based on a review of results from the CAM2038 clinical trial program that included seven Phase 1-3 clinical trials, five of which were in patients with OUD, including a pivotal Phase 3 efficacy and Phase 3 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 reactions.
CAM2038 will be supplied as ready-for-use prefilled syringes for weekly or monthly administration by a healthcare professional.
Braeburn is 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.braeburnrx.com.
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