Camurus announces that Braeburn receives Complete Response Letter for Brixadi for opioid use disorder in the US
Lund, Sweden — 2 December 2020 — Camurus AB (NASDAQ STO: CAMX) today announced that Camurus licensee Braeburn has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its new drug application (NDA) for Brixadi™ (buprenorphine) extended-release weekly and monthly injections for the treatment of moderate to severe opioid use disorder. The CRL follows a recent pre-approval inspection of Braeburn’s third-party manufacturer of Brixadi in the US, during which quality related deficiencies were identified. According to Braeburn, they are committed to