Data from Pharmawand - Curated by EPG Health - Date added 15 May 2018
Braeburn announced that the results from its Phase III study to evaluate the efficacy and safety of CAM 2038 (buprenorphine) weekly and monthly subcutaneous injection for the treatment of adults with moderate-to-severe opioid use disorder (OUD), have been published online in the Journal of the American Medical Association (JAMA) Internal Medicine. In this study, CAM2038 met the primary endpoint of non-inferiority versus daily sublingual buprenorphine/naloxone (current Standard of Care) and demonstrated superiority for the key secondary endpoint.
The Phase III study was designed to reflect real-world application and enrolled 428 patients with OUD, including those with concomitant use of other substances of abuse at baseline. CAM 2038 achieved primary endpoint of statistical non-inferiority compared to the active comparator of daily sublingual buprenorphine/naloxone (SL BPN/NX) for the pre-specified endpoint of responder rate (RR) (CI -4.0%, 9.9%; p<0.001). Importantly, the secondary endpoint (Cumulative Distribution Function of the mean percentage of opioid-negative samples confirmed by self-report) demonstrated statistically superior treatment effect (p=0.004). The overall safety profiles were comparable between the two treatment groups, with few serious adverse events reported for the CAM 2038 and SL BPN/NX (3.2% vs 6.0%, respectively).
See: "Weekly and Monthly Subcutaneous Buprenorphine Depot Formulations vs Daily Sublingual Buprenorphine With Naloxone for Treatment of Opioid Use Disorder: A Randomized Clinical Trial," Michelle R. Lofwall et al. JAMA Intern Med. Published online May 14, 2018. doi:10.1001/jamainternmed.2018.10520>