Camurus AB announced that its US licensee Braeburn has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its updated New Drug Application (NDA) for Brixadi™ (buprenorphine) extended-release injections for the treatment of opioid use disorder. The CRL is a result of continued quality related deficiencies at Braeburn's US based third party manufacturer, identified by the FDA during a pre-approval inspection.