FDA approves Sublocade to treat moderate to severe opioid use disorder

1 December 2017

The US Food and Drug Administration has approved Sublocade (buprenorphine extended- release) injection for subcutaneous use (CIII), the first and only once-monthly injectable buprenorphine formulation for the treatment of moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a transmucosal buprenorphine-containing product followed by dose adjustment for a minimum of seven days.

Developed by UK-based Indivior (LSE: INDV), formed following a demerger from Reckitt Benckiser in December 2014, Sublocade is intended to be administered only by healthcare providers and should be used as part of a complete treatment program that includes counseling and psychosocial support. Sublocade is expected to be available to patients in the USA in first-quarter 2018.

Indivior’s shares shot up 9.8% to 407.10 pence in morning trading today.

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