Hetero Labs Gets CDSCO Panel Nod To Study Antipsychotic Drug Brexpiprazole Tablets

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to Hetero Labs for conducting a bioequivalence study (BE) of the antipsychotic drug Brexpiprazole tablets 0.25/0.5mg/1mg/2mg/3mg/4mg.

Furthermore, the expert panel recommended revising the Phase III clinical trial protocol to align with the study title, including a qualified psychiatrist, and increasing the number of government site enrollments.

This came after Hetero Labs presented their proposal for a grant of permission to conduct the BE study (Protocol No BIOS/2023/204, Version-01, dated: 29.03.2024) and Phase III Clinical Trial study (protocol no.: HCR/III/BRXSP/06/2023, Version 1.0, dated: 11.07.2023) for Brexpiprazole Tablets before the committee.

Brexpiprazole is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain. Brexpiprazole is used to treat mental conditions, including depression and schizophrenia. It is also used to treat agitation that may happen with dementia caused by Alzheimer's disease. Brexpiprazole is an antipsychotic agent. It works in the brain to change how certain chemicals affect patients.

At the recent SEC meeting for Neurology and Psychiatry held on 28th January 2025, the expert panel reviewed the proposal for a grant of permission to conduct the BE study (Protocol No BIOS/2023/204, Version-01, dated: 29.03.2024) and Phase III Clinical Trial study (protocol no.: HCR/III/BRXSP/06/2023, Version 1.0, dated: 11.07.2023) for Brexpiprazole Tablets.

After detailed deliberation, the committee recommended granting permission for the grant to conduct a bioequivalence study as per the protocol presented and Phase III Clinical Trial with the following changes:

1. The firm should revise the title of the study with respect to (w.r.t.) newly diagnosed patients of schizophrenia to adults with acute schizophrenia.

2. The firm should include a qualified psychiatrist by training and experience as the principal investigator, as the drug (brexpiprazole) will be evaluated in psychiatric patients.

3. The firm should enroll more number of government sites.

Accordingly, the expert panel suggested that the firm should submit the revised protocol to CDSCO.

Furthermore, the committee added that the firm should submit the BE study report to CDSCO for review by the SEC committee before initiating the Phase III Clinical Trial.

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