Camurus announces Braeburn resubmits New Drug Application for Brixadi™ in the US
Lund, Sweden — 15 June 2021 — Camurus AB (NASDAQ STO: CAMX) today announced that its US licensee Braeburn has resubmitted the New Drug Application (NDA) for Brixadi[1] (buprenorphine) extended-release weekly and monthly injections for the treatment of moderate to severe opioid use disorder to the US Food and Drug Administration (FDA). The resubmission is in response to the Complete Response Letter (CRL) issued by the FDA to Braeburn on 1 December 2020 citing deficiencies identified during a pre-approval inspection of Braeburn’s third-party manufacturer in the US. A Prescription Drug