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FDA accepts Indivior’s new drug application for schizophrenia treatment

The FTSE 250 drugmaker said the acceptance is a “significant milestone” for the treatment
depressed woman
Schizophrenia is a chronic disorder characterised by a life-long pattern of acute psychotic episodes

Indivior PLC (LON:INDV) has taken a big step towards marketing its new schizophrenia treatment in the US after the Food and Drug Administration accepted a new drug application.

On Tuesday the FTSE 250 drugmaker said it will now work closely with the FDA which it hopes will formally approve RBP-7000 – an investigational once-monthly injectable to treat the disorder – further down the line.

READ: Indivior shares surge on FDA approval for monthly treatment as US battles opioid epidemic

Results from the phase III study were released earlier this year which showed that patients’ conditions either remained stable or improved over a 12-month period.

“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 chief scientific officer Christian Heidbreder.

“We look forward to closely working with the Agency during the review process to support the approval of RBP-7000 and to provide both physicians and patients this innovative treatment option.”

READ: Indivior submits new drug application to US FDA for injectable schizophrenia treatment

Earlier this month, Indivior’s experimental drug to help fight opioid addiction was approved by the FDA.

Shares rose 0.7% to 377.8p on Tuesday.

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