LoA Update: Teva’s extended-release risperidone for schizophrenia sees 5-point boost in regulatory potential following positive Phase III study

William Newton 31st March 2021 (Last Updated April 1st, 2021 04:52)

The likelihood of approval (LoA) for Teva Pharmaceutical’s TV-46000/mdc-IRM (extended-release subcutaneous risperidone) in schizophrenia rose 5 points as of 23 March, according to GlobalData’s LoA data.

LoA Update: Teva’s extended-release risperidone for schizophrenia sees 5-point boost in regulatory potential following positive Phase III study
The score change was driven by a Phase III risperidone trial meeting its primary endpoint of delay in time to relapse versus placebo. Credit: My Ocean Production/ Shutterstock.com

The likelihood of approval (LoA) for Teva Pharmaceutical’s TV-46000/mdc-IRM (extended-release subcutaneous risperidone) in schizophrenia rose 5 points as of 23 March, according to GlobalData’s LoA data. The score change was driven by a Phase III risperidone trial meeting its primary endpoint of delay in time to relapse versus placebo, which was announced in a 7 January company press release.

The 543-patient Phase III RISE trial demonstrated an 80% and 62.5% reduction in the relative risk to relapse with monthly (q1M) and once every two months (q2M) risperidone injections respectively, compared to placebo over the course of 15 months (p<0.0001). A second ongoing 331-patient Phase III SHINE study is measuring the frequency of adverse events with q1M or q2M risperidone injections for up to 56 weeks. Interim SHINE results align with safety findings from RISE, the company press release said. SHINE has an estimated primary completion date of YE21, according to ClinicalTrials.gov.

Prior to this news, the LoA score based on GlobalData’s analysis, which uses a combination of machine learning and a proprietary algorithm, was 46%. Teva’s product is an extended release injectable formulation of risperidone, a widely used antipsychotic, that uses a polymer delivery platform to provide greater control over of dosing and duration of drug release, according to the company. Teva has a market cap of $12.03bn.

William Newton is a Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.