Sun Pharma gets CDSCO Panel nod to study Lumateperone Capsules
New Delhi: The Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has granted permission to drug major Sun Pharma Laboratories for the conduct of Phase III clinical trial of Lumateperone capsules 42mg, a novel 2nd generation antipsychotic used to manage both positive and negative symptoms in patients with schizophrenia.
Additionally, the expert panel stated that the firm should revise the protocol with respect to the inclusion criteria to enroll patients with upper age limits up to 65 years instead of 75 years.
This came after the drug major Sun Pharma Laboratories presented the proposal for manufacturing and marketing of Lumateperone capsule 42mg along with the results of bioequivalence (BE) studies and Phase III clinical trial protocol before the committee.
Lumateperone is a novel 2nd generation antipsychotic used to manage both positive and negative symptoms in patients with schizophrenia.
Lumateperone is approved for the treatment of schizophrenia in adults. It is also approved for the treatment of depressive episodes associated with bipolar disorder (i.e. bipolar depression) in adults, as monotherapy and/or adjunctive therapy with lithium or valproate.
Lumateperone's mechanism of action involves simultaneous modulation of dopaminergic, serotonergic, and glutamatergic neurotransmission. This activity describes the indications, mechanism of action, and administration of lumateperone as a valuable treatment of schizophrenia.
At the recent SEC meeting for Neurology and Psychiatry held on 13th June 2023, the expert panel reviewed the proposal presented by Sun Pharma Laboratories for manufacturing and marketing of Lumateperone capsule 42mg along with the results of bioequivalence studies and Phase III clinical trial protocol.
After detailed deliberation, the committee recommended the grant of permission to conduct a Phase III clinical trial as per the protocol presented by the firm subject to the condition that the firm should revise the protocol with respect to the inclusion criteria to enroll patients with the upper age limits up to 65 years instead of 75 years.
