A long-term safety study of the extended-release formulation of buprenorphine for opioid use disorder (OUD) has identified a safety profile comparable to that of traditional sublingual buprenorphine. Published online this month in the Journal of Clinical Psychopharmacology, the study concluded that injection site reactions are the main additional area of concern regarding the monthly injectable formulation of buprenorphine.
The study of the extended-release drug, marketed by Indivior under the brand name Sublocade, encompassed 257 participants from an earlier Phase 3 study of the drug and 412 new participants who had never before received the medication. A total of 60.7% of participants completed the study, receiving up to 12 monthly injections of the OUD drug. The researchers found that 66.8% of participants reported more than one treatment-emergent adverse event, with fewer of these events in the second six months of treatment compared with the first six months.
The study revealed no treatment-emergent adverse events related to respiratory depression. The liver safety profile for Sublocade suggested a pattern comparable to that of traditional buprenorphine.
After 12 months, 61.5% of participants from the earlier study and 75.8% of the new participants were free of illicit opioids, the researchers reported.
“Data from this open-label study provide additional scientific evidence in support of the long-term safety profile of Sublocade and may help clinicians to determine how best they can help patients achieve and maintain recovery,” Indivior chief scientific officer Christian Heidbreder said in a news release from the pharmaceutical company.