Indivior PLC published compelling results from a multicenter, open-label clinical trial published in JAMA Network Open. Two approaches were evaluated for initiating treatment with SUBLOCADE®?, extended-release buprenorphine, in individuals who met criteria for moderate-to-severe opioid use disorder (OUD) and who engage in high-risk opioid use--including injection use, high-dose consumption, or fentanyl use. The study found that rapid induction--administration of a single dose of 4-mg oral buprenorphine followed by a same-day SUBLOCADE injection-- was well tolerated and led to higher retention at the second injection compared to standard induction, which is at least seven days of oral buprenorphine dose adjustments prior to the first injection of SUBLOCADE.
These benefits were observed across the full study population and were especially pronounced among fentanyl-positive participants, addressing the clinically relevant outcome that patients remain engaged with treatment after induction. The trial also demonstrated that administering the second SUBLOCADE injection just one week after the first was well tolerated in both treatment arms as the safety profile up to injection two was comparable, reinforcing the potential for an agile and patient-centered treatment model with rapid induction. A similar proportion of participants in adverse events up to injection two.
Study limitations include its open-label design, which could introduce some reporting bias, although there was no evidence of patient and provider preference for either strategy. About SUBLOCADE®? SUBLOCADE®?
(buprenorphine extended-release) injection, for subcutaneous use, CIII INDICATION and HIGHLIGHTED SAFETY information: 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. 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.
Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be used 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 withbuprenorphine.
Warn patients of the potential danger of self-administration of benzodiazepines or other CNS disorders while under treatment with SUBLOCADE. Risk of Serious Injection Site Reactions: Like the drug, drug-related drug-related drug-related, SUBLOCADE injection was not only effective but also well tolerated.
