JnJ gets CDSCO Panel nod to study antipsychotic drug Paliperidone Palmitate
New Delhi: Pharmaceutical major, Johnson and Johnson has got a go ahead from the Subject Expert Committee SEC functional under Central Drug Standard Control Organization CDSCO to conduct Phase III clinical trial for antipsychotic Paliperidone Palmitate Prolonged Release Suspension for intramuscular injection 700 mg and 1000 mg, 6 months injection (PP6M) in India.
This came after the drug maker Johnson and Johnson represented comparative efficacy/safety data of PP6M Vs PP3M and PP6M vs PP1M of global clinical trial in global and ethnic Indian (or Indian Origin) patients.
Paliperidone palmitate is a long-acting injectable formulation of paliperidone palmitoyl ester. Paliperidone Palmitate is used to treat certain mental/mood disorders (such as schizophrenia, schizoaffective disorder). Paliperidone is an antipsychotic drug (atypical type). It works by helping to restore the balance of certain natural chemicals (neurotransmitters) in the brain.
Paliperidone acts mainly by blocking the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin), which are involved in schizophrenia. By blocking these receptors, paliperidone helps to normalise the activity of the brain and reduce symptoms.
At the recent SEC meeting for Neurology and Psychiatry held on September 15th 2022,the expert panel extensively evaluated Johnson and Johnson's presentation on comparative efficacy/safety data of PP6M Vs PP3M and PP6M vs PP1M of global clinical trial in global and ethnic Indian (or Indian Origin) patients.
The committee noted that there is no country where PP6M (6 months injection) is marketed without the approval of PP3M (3 months injection). In addition, the committee also opined that the patients recruited from India in global clinical trial are less in number.
After detailed deliberation, the committee recommended the conduct of Phase III clinical trial of the Paliperidone Palmitate in India. Furthermore, the expert panel directed that the firm should submit the Phase III clinical trial protocol for further evaluation.
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