Camurus announces that Braeburn resubmits NDA for Brixadi in the US


23 November 2022 - Camurus today announced that its US licensee Braeburn has resubmitted the new drug application for Brixadi (buprenorphine) extended release subcutaneous injection (Schedule III Controlled Substance) for the treatment of moderate to severe opioid use disorder to the US 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.

Read Camurus press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier