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(September 21, 2018)
PLYMOUTH MEETING, Pa., Sept. 21, 2018 /PRNewswire/ -- Braeburn announces that Camurus has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the marketing authorization of CAM2038, an investigational buprenorphine flexible-dose weekly and monthly subcutaneous depot injection for the treatment of adults age 16 and older with opioid dependence. A final decision on market authorization of CAM2038 is expected from the European Commission by the end of November 2018.
"The positive CHMP opinion represents a step forward in helping to address the unmet need for effective alternatives to treat opioid dependence for patients in Europe," said Mike Derkacz, President and CEO of Braeburn. "Congratulations to the Camurus team for reaching this important milestone as they prepare for the commercialization of CAM2038 in the EU, while we focus our efforts to bring this important treatment to healthcare professionals and patients in the U.S. who are suffering from opioid use disorder."
Braeburn is the U.S. New Drug Application holder of CAM2038 which is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of adults with moderate-to-severe opioid use disorder (OUD) and has been assigned a target action date of December 26, 2018. If approved by the FDA, CAM2038 will provide patients and healthcare professionals with flexible-dose weekly and monthly options for the treatment of moderate-to-severe opioid use disorder, with the goal of improving treatment adherence and reducing the burdens associated with daily medication.
CAM2038 was studied in 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. If approved in the U.S., CAM2038 will be distributed through a REMS program to ensure product is only administered by a healthcare professional.
CAM2038 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, to be used as a part of a comprehensive treatment plan to include counseling and psychosocial support. 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 FDA's Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee jointly voted 17-3 for recommending approval of CAM2038.
CAM2038 will be marketed in Europe by Camurus under the registered trade name BuvidalŪ.
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.
For additional information, please contact:
Colleen Saltmer: [email protected]
Chris Taylor: [email protected]
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