Swedish biopharmaceutical company Camurus AB (NASDAQ:CAMX) (STO:CAMX) announced on Monday that it has filed a request for final approval of Brixadi (buprenorphine) with the US Food and Drug Administration (FDA), in a weekly and monthly extended release injection for the treatment of opioid use disorder.

The submission was initiated by the company's US partner Braeburn.

On 21 December 2018, Brixadi was tentatively approved by the US FDA, having met all regulatory requirements regarding efficacy, safety and quality and with this new request, Braeburn has submitted all updates for a final approval decision in the US on 1 December 2020.

Brixadi is a weekly (8mg, 16mg, 24mg, 32mg) and monthly (64mg, 96mg, 128mg) extended release buprenorphine injection for the treatment of opioid use disorder. The pivotal Phase 3 efficacy and safety trial demonstrated that Brixadi met the primary endpoint of non-inferiority for responder rate versus current standard of care and superiority for the secondary endpoint, concluded the company.