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.
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