Sun Pharma Laboratories Gets CDSCO Panel Nod To Manufacture Market Antipsychotic Lumateperone Capsule

New Delhi: The pharmaceutical major Sun Pharma Laboratories has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market antipsychotic drug Lumateperone capsules 42 mg.

However, this nod is subject to the condition that the firm should conduct a Phase IV clinical trial (CT) on Lumateperone capsules 42 mg, for which the Phase IV CT protocol should be submitted to CDSCO within 3 months of approval for further evaluation by the committee.

Furthermore, the expert panel stated that the drug should be sold by retail under the prescription of a neurologist or psychiatrist only.

This came after Sun Pharma Laboratories presented the Phase III CT report of lumateperone capsules 42 mg before the committee.

Lumateperone is a medication used to manage and treat schizophrenia and other neuropsychiatric disorders. It is a second-generation atypical antipsychotic medication that exhibits a novel mechanism of action. Lumateperone's mechanism of action involves simultaneous modulation of dopaminergic, serotonergic, and glutamatergic neurotransmission.

Lumateperone has partial agonist activity at presynaptic dopamine (D2) receptors, resulting in reduced presynaptic release of dopamine, and antagonistic activity at postsynaptic dopamine (D2) receptors. These characteristics allow lumateperone to efficiently reduce dopamine signaling.

Lumateperone also targets dopamine (D1) receptors, and a useful secondary result of D1 activation is increased glutamatergic N-methyl-D-aspartate (NMDA) GluN2B receptor phosphorylation. This is significant since NMDA-mediated glutamate signaling appears to be impaired in patients with schizophrenia.

Earlier, the Medical Dialogues Team had reported that the Central Drug Standard Control Organization (CDSCO) Panel had granted permission to drug major Sun Pharma Laboratories to conduct a Phase III clinical trial of lumateperone capsules 42 mg and had suggested revising the protocol with respect to the inclusion criteria to enroll patients with upper age limits up to 65 years instead of 75 years.

In continuation, at the recent SEC meeting for Neurology and Psychiatry, the expert panel reviewed the Phase III CT report of Lumateperone capsules 42 mg presented by Sun Pharma Laboratories.

After detailed deliberation, the committee recommended the grant of permission to manufacture and market the drug Lumateperone capsules 42 mg for the proposed indication, subject to the condition that:

(a) The firm should conduct Phase IV CT on Lumateperone capsules 42 mg for which Phase IV CT protocol should be submitted to CDSCO within 3 months of approval for further evaluation by the committee.

(b) The drug should be sold by retail under the prescription of a Neurologist or Psychiatrist only.

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