Camurus announces that Braeburn resubmits NDA for Brixadi™ in the US
Lund, Sweden — 23 November 2022 — Camurus AB (NASDAQ STO: CAMX) today announced that its US licensee Braeburn Inc. has resubmitted the New Drug Application (NDA) for Brixadi[*] (buprenorphine) extended-release injection for subcutaneous (SC) use (Schedule III Controlled Substance) for the treatment of moderate to severe opioid use disorder to the US Food and Drug Administration (FDA). The resubmission is in response to a Complete Response Letter issued by the FDA in December 2021 which cited deficiencies at Braeburn’s third-party manufacturing facility. A Prescription Drug User Fee Act (