Indivior PLC announced the publication of long-term safety data for SUBLOCADE® (buprenorphine extended-release) injection, for subcutaneous use (CIII). The manuscript entitled "Treating Opioid Use Disorder with a Monthly Subcutaneous Buprenorphine Depot Injection: 12-month Safety, Tolerability and Efficacy Analysis" was published online on April 9, 2020 and will appear in an upcoming print issue of the Journal of Clinical Psychopharmacology. This open-label multicenter study (NCT 02510014) in adults with moderate or severe opioid use disorder (OUD) enrolled 257 participants from a previously conducted placebo-controlled, double-blind Phase III trial (Rollover group) and 412 De Novo participants not previously treated with SUBLOCADE. By study end, 60.7% participants completed the study and received up to 12 injections. The main findings were as follows: The safety profile of up to 12-month SUBLOCADE treatment was consistent with that of transmucosal buprenorphine, with the exception of the anticipated injection-site reactions. Overall, 66.8% of participants reported >1 treatment-emergent adverse event (TEAE). Injection-site TEAEs (13.2% of participants), were mostly mild or moderate in severity. An integrated analysis of the double-blind and open-label study participants showed that the incidence of TEAEs, including injection-site TEAEs, were lower in the second 6 months of treatment versus the first 6 months. There were no unexpected safety signals detected and no TEAEs potentially related to respiratory depression. The hepatic safety profile of SUBLOCADE was comparable to that reported for transmucosal buprenorphine and longer exposure to the highest 300 mg maintenance dose of SUBLOCADE did not worsen hepatic laboratory assessments. There were no cases of hepatocellular injury indicated by increased AST/ALT with jaundice and no removal of SUBLOCADE was required. Efficacy was evaluated using Urine Drug Screen for opioids plus self-reported illicit opioid use combined into a single endpoint. After 12 months of SUBLOCADE treatment, 61.5% of the Rollover participants and 75.8% of the De Novo participants were free of illicit opioid use. INDICATION AND USAGE: SUBLOCADE® (buprenorphine extended-release) injection, for subcutaneous use (CIII) is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product followed by a dose adjustment period for a minimum of seven days. SUBLOCADE should be used as part of a complete treatment program that includes counseling and psychosocial support.