The FDA has approved Sublocade (Indivior, Inc.), the first once-monthly buprenorphine injection for the treatment of moderate-to-severe opioid use disorder (OUD) in adults 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 at least seven days.

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

Sublocade should be used as part of a complete treatment program that includes counseling and psychosocial support. It is a drug–device combination product that utilizes buprenorphine and the Atrigel delivery system in a prefilled syringe. It is injected subcutaneously by a health care professional as a solution and forms a solid deposit, or depot, containing buprenorphine. Buprenorphine is released by the biodegradation of the depot. In clinical trials, Sublocade provided sustained therapeutic plasma levels of buprenorphine over the one-month dosing interval.

The safety and efficacy of Sublocade were evaluated in two clinical trials of 848 adults with a diagnosis of moderate-to-severe OUD who began treatment with buprenorphine/naloxone sublingual film. Once the dose was determined stable, patients were given Sublocade by injection. Sublocade-treated patients had more weeks without positive urine tests or self-reports of opioid use, and a higher proportion of patients had no evidence of illicit opioid use throughout the treatment period, compared with the placebo group.

The FDA is requiring post-marketing studies to assess which patients would benefit from a higher dosing regimen, to determine whether Sublocade can be safely initiated without a dose stabilization period of sublingual buprenorphine, to assess the feasibility of administering Sublocade at a longer interdose interval than once monthly, and to determine a process for transitioning patients with long-term stability on a transmucosal buprenorphine dose to a monthly dose of Sublocade without the use of a higher dose for the first two months of treatment.

Sublocade has a boxed warning that includes the risks of intravenous self-administration. If the product is administered intravenously, the solid mass could cause occlusion, tissue damage, or embolus. Sublocade must be prescribed and dispensed under a risk evaluation and mitigation strategy.

Source: FDA, November 30, 2017