공시 • May 22
Indivior Pharmaceuticals Announces Findings From Real-World Evidence Studies on Monthly Injectable Buprenorphine (SUBLOCADE)
Indivior Pharmaceuticals, Inc. announced findings from two new real-world evidence studies showing that adherence to extended-release buprenorphine, a monthly injectable commercially available as SUBLOCADE®, is associated with lower relapse risk, fewer infection-related complications, and reduced healthcare utilization among people living with opioid use disorder (OUD). One retrospective claims analysis, published in Drug and Alcohol Dependence Reports, analyzed 3,400 patients’ 12-month adherence rates to monthly injectable buprenorphine and its association with return to opioid use. Patients adherent to extended-release buprenorphine were 3.5 to 8.1 times less likely to return to opioid use compared to other groups who were non-adherent, or adherent to other forms of MOUD. Additional relapse risk factors included younger age, male sex, Medicaid coverage, urban residence, comorbid alcohol or other substance use disorders, skin infections, and limited prior engagement with buprenorphine treatment before initiation of the extended-release injection. A second retrospective cohort study, published in The Journal of Substance Use and Addiction Treatment, compared infectious disease outcomes and healthcare utilization between 467 patients receiving monthly injectable buprenorphine and nearly 120,000 patients on daily oral buprenorphine. Patients adherent to extended-release buprenorphine had a 62% reduction in bacteremia incidence (bloodstream infections) compared to those adherent to oral buprenorphine. Furthermore, patients in the extended-release buprenorphine group had lower overall healthcare utilization during the 6-month follow-up. This included 56% fewer inpatient visits, 22% fewer ED visits, 21% fewer all-cause outpatient visits, and 77% fewer sexually transmitted infections-related outpatient visits. As both studies were retrospective real-world evidence analyses using existing claims and electronic health record data, these findings should be viewed in the context of the study designs and data-source possibilities. Findings from the relapse analysis, published in Drug and Alcohol Dependence Reports, are available. Relapse was identified using claims-based proxy measures, and some treatment or outcome events may not have been fully captured in administrative claims data, including during the COVID-19 pandemic. The infectious disease and healthcare utilization analysis, published in The Journal of Substance Use and Addiction Treatment, is available. This analysis may not capture care received outside the data network. The size and duration of the extended-release cohort may limit precision for some comparisons. Both studies were funded by Indivior and conducted in partnership with external academic and research collaborators using large U.S. claims and electronic health record–linked datasets. SUBLOCADE® (buprenorphine extended-release) injection, for subcutaneous use, CIII. SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support. WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY. Serious harm or death could result if administered intravenously. SUBLOCADE forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life-threatening pulmonary emboli, if administered intravenously. Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE is only available through a restricted program call the SUBLOCADE REMS Program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with the REMS requirements. Hypersensitivity to buprenorphine or any other ingredients in SUBLOCADE. Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors. Respiratory Depression: Life threatening respiratory depression and death have occurred in association with buprenorphine. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with SUBLOCADE. Risk of Serious Injection Site Reactions: Likelihood may increase with inadvertent intramuscular or intradermal administration. Evaluate and treat as appropriate. The most common injection site reactions are pain, erythema, and pruritus with some involving abscess, ulceration, and necrosis. Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy. Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment with SUBLOCADE is discontinued, monitor patients for several months for withdrawal and treat appropriately. Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to and during treatment. Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patients have tolerated transmucosal buprenorphine before injecting SUBLOCADE. Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect. Adverse reactions commonly associated with SUBLOCADE (in =5% of subjects) were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue, and injection site pain. For more information about SUBLOCADE, the full Prescribing information including BOXED WARNING, and Medication Guide, visit.