Braeburn receives new Complete Response Letter for Brixadi in the US

Camurus AB (NASDAQ STO: CAMX) today 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.

“We are very disappointed to learn of the new Complete Response Letter for Brixadi and the continued deficiencies at Braeburn’s US manufacturer. Regrettably, this comes at a time when the opioid crisis continues to worsen and access to new effective treatment options for opioid use disorder are urgently needed”, says Fredrik Tiberg, President and CEO of Camurus. “Camurus is seeking further information from Braeburn and will consider all options to ensure that Brixadi becomes available to US patients as soon as possible.”

Camurus will provide further updates as soon as additional relevant information has been received from Braeburn.