PRINCETON, N.J. and LUND, Sweden, Nov. 14, 2016 /PRNewswire/ -- America's opioid crisis is taking the life of a person every 19 minutes. Responding to this crisis, Braeburn Pharmaceuticals and Camurus (NASDAQ STO: CAMX) are pleased to announce positive top-line results from a pivotal Phase 3 randomized, double-blind, double-dummy, active controlled trial of weekly and monthly injections of buprenorphine (CAM2038) for treatment of moderate-to-severe opioid use disorder. In addition to achieving the primary endpoint of non-inferiority versus daily sublingual buprenorphine/naloxone (current Standard of Care), CAM2038 also demonstrated superiority for the key secondary endpoint.
"We are pleased with these significant clinical trial results, which show that our CAM2038 injectable buprenorphine products, if approved, can provide effective new solutions for patients and physicians," said Behshad Sheldon, President and CEO of Braeburn Pharmaceuticals. "Opioid addiction is an overwhelming public health epidemic. In the United States alone, there are 2.6 million patients diagnosed with opioid addiction, and approximately 30,000 people die every year from opioid overdoses. CAM2038 comes in both weekly and monthly formulations, each in a range of dosage strengths, in alignment with clinical practice of treating opioid addiction, where different patients have different and evolving needs as they progress from treatment initiation to stabilization and eventually long-term maintenance. We believe that our CAM2038 products, together with our recently approved Probuphine 6-month buprenorphine implant, have the potential to transform the treatment of opioid addiction." In the Phase 3 study enrolling 428 patients with opioid use disorder, CAM2038 achieved the main objective of statistical non-inferiority compared to the active comparator of SL BPN/NX for both the FDA and the EMA specified endpoints of responder rate (RR) (CI -3.5%, 10.4%; p<0.001) and percent negative urine samples for opioids (CI -0.2%, 13.7%; p<0.001), respectively.