Buprenorphin-Depot: FDA issues complete response letter for CAM2038 for opioid use disorder
Buprenorphin-Depot: FDA issues complete response letter for CAM2038 for opioid use disorder
Lund, Sweden — 21 January 2018 — Camurus (NASDAQ STO: CAMX) today announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the new drug application (NDA) for CAM2038, investigational buprenorphine weekly and monthly depot injections, for the treatment of adults with opioid use disorder (OUD). The FDA has requested additional information to complete the review. There is no need for new clinical studies and the Agency’s requests will be addressed in a timely manner.
“The FDA has issued a complete response letter that will serve as road map for approval and we are confident that the questions raised by the Agency can be effectively managed and resolved”, said Fredrik Tiberg, President & CEO of Camurus. ”Our US partner Braeburn Pharmaceuticals will work closely with the FDA with the goal of bringing CAM2038 to market as quickly as possible.”
CAM2038 has received Fast Track status for treatment of OUD. The NDA was granted FDA Priority Review on 18 September 2017 and FDA Advisory Committee recommended approval on 1 November 2017. If approved, CAM2038 would be the first and only long-acting injectable for individualized treatment of OUD that can be used from start of treatment Day 1 and throughout patients' recovery. (Camurus, Lund/Schweden, 21.01.2018)