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FDA Approves Injectable Form of Buprenorphine
FDA news release; 2017 Nov 30
The US Food and Drug Administration (FDA) has approved Sublocade, the first once-monthly injectable buprenorphine product for the treatment of moderate-to-severe opioid use disorder (OUD) in adult patients who have initiated treatment with a transmucosal (absorbed through mucus membrane) buprenorphine-containing product. It is indicated for patients that have been on a stable dose of buprenorphine treatment for a minimum of 7 days.
Indications: Buprenorphine for the treatment of OUD is currently approved to administer as a tablet or film that dissolves in the mouth, or as an implant. Sublocade provides a new treatment option for patients in recovery who may value the benefits of a once-monthly injection compared to other forms of buprenorphine, such as reducing the burden of taking medication daily as prescribed.
Dosage/administration: Sublocade should only be prepared and administered by a healthcare provider. It is administered monthly only by subcutaneous injection in the abdominal region. The recommended dose of Sublocade is 2 monthly initial doses of 300 mg followed by 100 mg monthly maintenance doses. Increasing the maintenance dose to 300 mg monthly may be considered for patients in which the benefits outweigh the risks.
Adverse effects: 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.
FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder. FDA Web site. November 30, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587312.htm. Accessed December 7, 2017.