A priority review means US regulator the Food and Drug Administration will review a new drug application (NDA) within six months instead of the standard ten.
The NDA was submitted on May 30 based on data from a Phase 3 study of people addicted to opiods such as heroin, morphine and codeine.
"FDA acceptance with a Priority Review designation of our NDA application for RBP-6000 represents a significant milestone for our company as well as for the broader field of opioid use disorder treatment," said Shaun Thaxter, chief executive.
"If approved, RBP-6000 would represent the first once-monthly injectable buprenorphine treatment for OUD [opioid use disorder]."
The product is intended to be administered by healthcare professionals only, he added.
Indivior’s core products currently are the buprenorphine-based opiod abuse treatments Subutex (non-US) and Suboxone, for which it is facing multiple legal actions in the US over its marketing and promotion.