Pharmaceutical company Braeburn Pharmaceuticals Inc said on Monday that it has filed its New Drug Application (NDA) with Priority Review designation for CAM2038 for the treatment of opioid use disorder (OUD) with the US Food and Drug Administration (FDA).

The US FDA has granted Fast Track and Priority Review designations for the company's CAM2038 buprenorphine weekly and monthly depot for treating opioid use disorder and will convene an Advisory Committee meeting in Q4 2017. It has assigned a Prescription Drug User Fee Act (PDUFA) target action date of 19 January 2018.

In conjunction, the company stated that CAM2038 buprenorphine weekly and monthly depot subcutaneous injection is an investigational treatment of opioid use disorder, as a part of a comprehensive treatment plan to include counselling and psychosocial support. It is designed for flexible and individualised treatment from initiation and stabilization to longer-term maintenance therapy, providing sustained buprenorphine release in once weekly and once monthly formulations.

Concurrently, the NDA for CAM2038 comprises data from five Phase 1-2 clinical trials as well as two Phase 3 trials. If approved by the US FDA, CAM2038 will be offered in dosage strengths for once weekly (8 mg to 32 mg range) and once monthly (64 mg to 160 mg) subcutaneous injections, according to the company.

This study enrolled a wide OUD population including patients who had concomitant use of other non-opioid substances of abuse, such as amphetamines, cocaine, marijuana, and benzodiazepines. The safety profile of CAM2038 was generally consistent with the known safety profile of buprenorphine, with the exception of mild-to-moderate injection-site adverse events, concluded the company.