Indivior's schizophrenia drug application accepted by US FDA

The Food and Drug Administration will work with Indivior towards a decision on whether to approve RBP-7000, an injectable dose of risperidone via the Atrigel delivery system, as a marketable drug by late July next year.

Indivior submitted a new drug application for RBP-7000 in September after a Phase III trial that showed it produced a statistically significant clinical improvement compared to placebo after eight weeks for people with acute schizophrenia.

"FDA acceptance of our RBP-7000 NDA is a significant milestone for Indivior as we expand our treatment portfolio to offer a meaningful therapeutic option to help address non-compliance with medication administration in the treatment of schizophrenia," said Indivior's chief scientific officer, Christian Heidbreder.

An estimated 23m people around the world were recently said to be afflicted by schizophrenia, which is a chronic disorder where sufferers experience different combinations and different degrees of various psychotic episodes inlcuding delusions, hallucinations, social withdrawal, impaired sustained attention, executive function and working memory, anxiety and depression, hostility and aggression, and increased risk of suicide.