Sun Pharma gets CDSCO panel okay for phase 3 trial of Pimavanserin
New Delhi: Pharmaceutical major, Sun Pharma has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct a phase III clinical trial of antipsychotic drug Pimavanserin, used for the treatment of hallucinations and delusions caused by Parkinson's Disease.
This came in line with the revised phase III clinical trial protocol presented by drug giant Sun Pharma at recent SEC meeting for Neurology & Psychiatry.
Pimavanserin is an atypical antipsychotic used in the treatment of hallucinations and psychosis in patients with Parkinson disease.
The mechanism by which pimavanserin treats hallucinations and delusions associated with Parkinson's disease psychosis is not fully established. However, it is possible that pimavanserin acts via inverse agonist and antagonist activity at serotonin 5-HT2A receptors with limited effects on serotonin 5-HT2C receptors.
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.
