The advisory committee of the US Food and Drug Administration (FDA) has recommended the approval of Braeburn Pharmaceuticals' investigational buprenorphine depot, CAM2038, for the treatment of opioid use disorder.
Opioids
“The panel’s recommendation in favour of CAM2038 brings us another step closer to providing an individualised treatment option to support OUD patients from day one of their recovery, through initiation, to longer-term maintenance therapy,” explained Mike Derkacz, president and CEO of Braeburn. “The magnitude of the opioid crisis noted in the President’s Commission report today reinforces the need for new, medication assisted therapies such as CAM2038, which is administered by healthcare professionals ensuring medication adherence, while potentially minimising risks of diversion, abuse, misuse and accidental paediatric exposure.”
When asked to vote on the recommended approval of all, some or none of the proposed doses of CAM2038 by the FDA, the committee voted 17 in favour of the approval of some of the doses and three in favour of none of the doses.
The recommendation from the advisory committee was based on a review of results from a clinical trial programme, including seven Phase I–III clinical trials in patients with opioid use disorder (OUD). CAM2038 has been accepted under priority review designation by the FDA in September this year and has been set a Prescription Drug User Fee Act (PDUFA) target date of 19 January 2018.