Torrent Pharma gets CDSCO Panel nod to study Brexpiprazole tablet to treat schizophrenia
New Delhi: Citing that the clinical trial sites should be geographically distributed in the country, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Torrent Pharmaceutical's proposal to conduct the Phase III clinical trial of Brexpiprazole tablets 0.25mg, 0.5mg,1mg, 2mg, 3mg, 4mg indicated for the treatment of schizophrenia in adult patients.
This came after Torrent Pharmaceuticals presented the proposal for a grant of permission to manufacture and market Brexpiprazole tablets 0.25mg, 0.5mg, 1mg, 2mg, 3mg, and 4mg indicated for the treatment of schizophrenia in adult patients along with Phase III clinical trial protocol and bioequivalence (BE) study report before the committee.
Brexpiprazole is an atypical antipsychotic and a novel D2 dopamine and serotonin 1A partial agonist called serotonin-dopamine activity modulator (SDAM). It has a high affinity for serotonin, dopamine, and alpha (α)-adrenergic receptors.
Brexpiprazole is a serotonin–dopamine activity modulator used in the treatment of major depressive disorder as an adjunct, schizophrenia, and agitation associated with dementia due to Alzheimer’s disease.
Brexpiprazole is indicated as adjunctive therapy to antidepressants for the treatment of major depressive disorder in adults. It is also indicated for the treatment of schizophrenia in patients 13 years of age and older. Brexpiprazole is also indicated for the treatment of agitation associated with dementia due to Alzheimer’s disease.
At the recent SEC meeting for Neurology and Psychiatry held on the 8th and 9th of November 2023, the expert panel reviewed the proposal presented by the drug major Torrent for grant of permission to manufacture and market Brexpiprazole tablets 0.25mg, 0.5mg, 1mg, 2mg, 3mg, and 4mg indicated for the treatment of schizophrenia in adult patients along with Phase III clinical trial protocol and BE study report.
After detailed deliberation, the committee recommended conducting the Phase III clinical trial subject to the condition that the clinical trial sites should be geographically distributed in the country.
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