Indivior presented data From the RECOVER study, which evaluated the efficacy and long-term safety of once-monthly Sublocade (buprenorphine extended-release) injection for subcutaneous use (CIII) for the treatment of moderate to severe opioid use disorder, at the 50th Annual Conference of the American Society of Addiction Medicine (ASAM) in Orlando, Florida. Data showed that the duration of Sublocade use was associated with continuous abstinence from illicit opioids.
The RECOVER (Remission from Chronic Opioid Use—Studying Environmental and SocioEconomic Factors on Recovery) study enrolled 533 of 844 subjects who participated in a prior Phase 3 Sublocade clinical trial. Eighty percent of the enrolled subjects (425 of 533) completed the one-year RECOVER survey and more than 75% completed surveys and had urine drug screens to confirm abstinence at each earlier timepoint (baseline and 3, 6 and 9 months). Patients made independent decisions about continuing medication-assisted treatment (MAT). More than four in 10 patients (44%) were not on any MAT during the 12-month RECOVER period reported here, while 34% continued on Sublocade for six or fewer months through a safety extension study, and 22% receive another form of MAT through their personal healthcare provider for some portion of the 12-month period. Adjusted continuous abstinence rates for the year after the initial study ended ranged from a high of 75.3% for patients who had received 12 monthly Sublocade study doses to a low of 24.1% for patients who had received two or fewer study doses. No new safety issues were identified among 166 patients treated with Sublocade for up to 18 months. Injection-site reactions were mild to moderate in severity and the overall safety profile of Sublocade was consistent with that of transmucosal buprenorphine, and the frequency and severity of treatment-emergent adverse events (TEAEs) decreased over time.
Sublocade is approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe opioid use disorder in adult patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of seven days. Sublocade comes with a Black Box Warning: Serious harm or death could result if administered intravenously. Sublocade forms a solid mass upon contact with bodily 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 called the SUBLOCADE REMS Program.Source: www.indivior.com