Intas pharma gets CDSCO panel nod to manufacture, market schizophrenia drug Clozapine

This approval is subjected to the condition that the firm should conduct Phase IV clinical trial, and accordingly, the firm should submit the protocol for the conduct of a Phase IV clinical trial to CDSCO within 3 months from the date of approval of the drug.

This came in the wake of the proposal presented by the drug-maker Intas Pharmaceuticals for a modified release dosage form of the antipsychotic drug Clozapine along with the results of a bioequivalence (BE) study.

Clozapine was the first atypical antipsychotic approved for treatment of schizophrenia. Schizophrenia is a serious mental illness in which patients have abnormal perceptions of reality. Schizophrenia can cause hallucinations, delusions, and extremely abnormal thought and behaviour, which can make it difficult to function on a daily basis. Schizophrenia patients need to be treated forever.

Clozapine is a synthetic dibenzo-diazepine derivative that blocks several neurotransmitter receptors in the brain. Clozapine is a serotonin antagonist, with strong binding to the 5-HT 2A/2C receptor subtype. It also displays strong affinity for several dopaminergic receptors but shows only weak antagonism at the dopamine D2 receptor, a receptor commonly thought to modulate neuroleptic activity.

Clozapine's antipsychotic action is likely mediated through a combination of antogistic effects on D2 receptors in the mesolimbic pathway and 5-HT2A receptors in the frontal cortex.

At a recent SEC meeting for Neurology & Psychiatry, the committee extensively reviewed the proposal presented by the drug-maker Intas Pharmaceuticals for a modified release dosage form of the antipsychotic drug Clozapine along with the results of a bioequivalence (BE) study.

After detailed deliberation, the committee recommended the grant of permission for the manufacturing and marketing of Clozapine ER Capsules (12.5/25/50/100 & 200 mg) indicated for the management of schizophrenia in adult patients, subject to the condition that the firm conduct a Phase IV clinical trial.

Accordingly, the expert panel opined that the firm should submit the protocol for the conduct of a Phase IV clinical trial to CDSCO within 3 months from the date of approval of the drug.