Medication Monitor

Generic Name (Trade Name—Company)
December 1, 2017

Injectable buprenorphine

FDA approves first once-monthly buprenorphine injection for opioid use disorder

FDA has granted fast track approval to Sublocade, the first once-monthly injectable buprenorphine product for treatment of moderate-to-severe opioid use disorder (OUD) in adult patients who have initiated treatment with a transmucosal buprenorphine-containing product. It is indicated for patients who have been on a stable dose of buprenorphine treatment for a minimum of 7 days.

Buprenorphine for treatment of OUD is currently approved to administer as a tablet or film that dissolves in the mouth, or as an implant.

The drug–device combination product utilizes buprenorphine and the Atrigel Delivery System in a prefilled syringe. It is injected by a health professional subcutaneously as a solution, and the delivery system forms a solid deposit, or depot, containing buprenorphine. After initial formation of the depot, buprenorphine is released by the breakdown of the depot.

In clinical trials, Sublocade provided sustained therapeutic plasma levels of buprenorphine over the 1-month dosing interval.

The most common adverse effects include constipation, nausea, vomiting, headache, drowsiness, injection site pain, itching at the injection site, and abnormal liver function tests. Safety and efficacy have not been established in children or adolescents younger than 17 years of age. Clinical studies did not include participants older than age 65.

Sublocade has a boxed warning that provides important safety information, including the risks of I.V. self-administration. Sublocade must be prescribed and dispensed as part of a risk evaluation and mitigation strategy (REMS) and will be provided to health professionals through a restricted program.

Sublocade should be used as part of a complete treatment program that includes counseling and psychosocial support.