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.
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