The U.S. Food and Drug Administration approved Indivior PLC's Sublocade, a medication-assisted treatment option for moderate-to-severe opioid use disorder.
Sublocade, or extended-release buprenorphine, is a once-monthly injectable that can be used by adult patients who have initiated treatment with a transmucosal buprenorphine-containing product.
Sublocade was evaluated in two clinical trials, with results showing it fully blocked the drug-liking effects of opioid pain medication hydromorphone, and was shown to be superior to placebo in achieving more illicit opioid-free weeks, respectively.
The FDA is requiring postmarketing studies evaluating Sublocade in higher doses, without a stable dose of buprenorphine and at dose intervals longer than once-monthly. Indivior was also asked to determine a process for transitioning patients from buprenorphine to Sublocade without a loading dose.
The company expects to launch the drug in the U.S. in the first quarter of 2018.
