Submit Animal Toxicity Study Report: CDSCO Panel Tells Lupin on Parkinsonism FDC drug
New Delhi: Noting that the proposed dose is higher than the approved dose, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Lupin to submit the animal toxicity study report for the fixed-dose combination (FDC) of Carbidopa 70mg plus Levodopa 280 mg extended-release capsule.
This came after the drug major Lupin presented their proposal along with the Protocol of the bioequivalence (BE) study for export purposes only.
Carbidopa and levodopa combination is used to treat Parkinson's disease, sometimes called shaking palsy or paralysis agitans. Parkinson's disease is a disorder of the central nervous system (brain and spinal cord).
Dopamine is a naturally occurring substance in the brain that helps provide control of movement and activities such as walking and talking. In patients with Parkinson's disease, there is not enough dopamine in some parts of the brain.
Levodopa enters the brain and helps replace the missing dopamine, which allows people to function better. By increasing the amount of dopamine in the brain, levodopa helps control symptoms and helps you perform daily activities such as dressing, walking, and handling utensils.
Carbidopa is a medication used in the management and treatment of Parkinson's disease (PD). It is in the decarboxylase inhibitor class of drugs. Levodopa is the precursor to dopamine. Most commonly, clinicians use levodopa as a dopamine replacement agent for the treatment of Parkinson disease. It is most effectively used to control bradykinetic symptoms apparent in Parkinson disease.
The combination of levodopa and carbidopa is used to treat the symptoms of Parkinson's disease and Parkinson's-like symptoms that may develop after encephalitis (swelling of the brain) or injury to the nervous system caused by carbon monoxide poisoning or manganese poisoning
At the recent SEC meeting for Neurology and Psychiatry held on 18th and 19th January 2024, the expert panel reviewed the proposal along with the Protocol of the BE study for export purposes only.
After detailed deliberation, the committee recommended the submission of an animal toxicity study report as this dose was higher than the approved dose.
Accordingly, the expert panel suggested that the firm should submit the above data/document/information for re-deliberation by the SEC.
