Indivior's Once-Monthly Buprenorphine Clears US FDA With Box Warning, REMS

The US FDA approved Indivior PLC's Sublocade (buprenorphine extended-release), the first once-monthly injectable buprenorphine formulation for treatment of opioid use disorder, with a Risk Evaluation and Mitigation Strategy (REMS) requiring administration by a healthcare provider and several postmarket study requirements.

The product is indicated for treatment of moderate-to-severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of seven days