FDA approves once-monthly injectable buprenorphine product
The U.S. Food and Drug Administration (FDA) this week announced it has approved a once-monthly injectable buprenorphine product for the treatment of opioid use disorder in patients who have started treatment with a sublingual film buprenorphine-containing product, such as Suboxone. Sublocade, the once-monthly injectable, is designed for patients who have been on a stable dose of buprenorphine treatment for seven days.
Prior to its approval by the FDA, Sublocade was evaluated in two clinical studies of 848 adults with diagnoses of moderate-to-severe OUD who had begun treatment with a sublingual film buprenorphine product. Results showed patients treated with Sublocade had more weeks without positive urine tests or self-reports of opioid use, and a higher portion of patients exhibited no signs of illicit opioid use through the treatment period when compared with a placebo group.
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