Sun Pharma gets CDSCO panel okay for phase 3 trial of Pimavanserin

Pimavanserin is an inverse agonist and antagonist of serotonin 5-HT2A receptors with high binding affinity, demonstrating low binding affinity to serotonin 5-HT2C receptors. In addition, this drug exhibits low affinity binding to sigma 1 receptors. Pimavanserin lacks activity at muscarinic, dopaminergic, adrenergic, and histaminergic receptors, preventing various undesirable effects typically associated with antipsychotics.

Earlier, at 74th SEC meeting for Neurology & Psychiatry, in response to Sun Pharma's phase 3 clinical trial protocol, the expert panel opined that the firm should revised clinical trial protocol including as follows:

a) Sample size recalculation based on effect size etc., and prior publication data that is more relevant to their work and to accommodate multiple doses they were trying.

b) To define the study population criteria more specific, clarifying the type and duration and stages of the Parkinsonism.

At a recent SEC meeting for Neurology & Psychiatry, dated 18.01.2022 the committee extensively reviewed Sun Pharma's revised phase III clinical trial protocol for antipsychotic drug Pimavanserin.

After detailed deliberation, the committee recommended the grant of permission to conduct the phase III clinical trial.