Pharma Capital

Indivior granted US priority review for new monthly addiction treatment

A priority review means the US regulator, Food and Drug Administration, will review a new drug application (NDA) within six months
picture of syringe
RBP- 6000 wil be administered by healthcare professionals

Drug developer Indivior PLC (LON:INDV) has been granted a US Priority Review designation for RBP-6000, its new once-monthly injection for opioid addicts.

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.

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