Proactive Investors - Run By Investors For Investors

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.

View full INDV profile View Profile

Indivior Timeline

Related Articles

November 14 2018
The goal of the program is to extend the visualization extracted from 2D ultrasound images and visualize 4D images
December 03 2018
Since September, the group's portfolio has steamed ahead with a number of new and successful clinical trials, as well as a boost from the float of one of its companies on the Nasdaq
cholesterol on a dial
September 24 2018
"The formation of ProBiotix Health and appointment of Adam Reynolds as chairman continues a successful strategy of building value in each division which is materialised by forming separate legal entities and taking them to a public listing,” said chief executive Stephen O’Hara

© Proactive Investors 2018

Proactive Investors Limited, trading as “Proactiveinvestors United Kingdom”, is Authorised and regulated by the Financial Conduct Authority.
Registered in England with Company Registration number 05639690. Group VAT registration number 872070825 FCA Registration number 559082. You can contact us here.

Market Indices, Commodities and Regulatory News Headlines copyright © Morningstar. Data delayed 15 minutes unless otherwise indicated. Terms of use