Indivior applies for US FDA approval for schizophrenia drug, buys rival patent rights

Indivior has submitted a new drug application in the US for a once-monthly injectable schizophrenia treatment and agreed to buy out patent rights from a manufacturer of similar antipsychotic medication.

At the end of last week the FTSE 250 company filed an NDA with the US Food and Drug Administration for 'RBP-7000', an injectable version of antipsychotic medication risperidone that is administered via Atrigel, a slow-release drug delivery system.

Indivior, which makes most of its revenues from opioid addiction treatments, also said it had paid $12.5m up-front to Durect Corporation for "certain patent rights" to improve protection of RBP-7000, with a further $5m due upon NDA approval of RBP-7000 plus earn-out payments based on a low single-digit percentage of US sales of certain products covered by the patent rights.

The patent rights include a US patent that covers injectable sustained-release small molecule drug formulation, as well as pending applications in the same patent family.

Indivior's NDA submission for RBP-7000 included the results from a Phase 3 study testing the effectiveness and safety of the drug and a long-term safety study, which found the treatment demonstrated "statistically clinical improvement" compared to placebo based on changes in mean positive and negative syndrome scale total and clinical global impression-severity of illness scores at eight weeks.