Indivior announced the availability of Sublocade (buprenorphine extended-release) subcutaneous injection for the treatment of moderate to severe opioid use disorder (OUD) in adults who have initiated treatment with a transmucosal buprenorphine-containing product followed by a dose adjustment for ≥7 days.

Sublocade is intended for use as part of a complete treatment program that includes counseling and psychosocial support. It carries a Boxed Warning describing the risk of serious harm or death with intravenous (IV) administration. Sublocade is only available through a restricted program called the Sublocade REMS Program. Healthcare settings and pharmacies that order and dispense Sublocade must be certified in this program and comply with the REMS requirements.

The approval of Sublocade was supported by data from the Phase 3 RB-US-13-0001 study (N=504). The proportion of patients achieving treatment success (≥80% opioid-free weeks) was statistically significantly higher in both Sublocade 300mg and 100mg groups vs placebo (28.4%, 29.1%, and 2%, respectively).

Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor.

Sublocade, a CIII controlled substance, is available in 100mg/0.5mL and 300mg/1.5mL strengths as single-dose prefilled syringes.

For more information call (877) 782-6966 or visit Sublocade.com.