MSN Labs Gets CDSCO Panel Nod to Begin Phase III Trial of Cenobamate Tablets, With Safety Caveat
New Delhi: Considering the bioequivalence study results of the MSN Labs Cenobamate Tablets 12.5 mg, 25 mg, 50mg, 100 mg, 150 mg & 200 mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) recommended to conduct the Phase III clinical trial of the proposed drug.
However, this approval is subjected to the condition that the firm should include detailed safety evaluation of subjects and causality assessment of adverse drug reactions in the protocol.
This came after the firm presented BE study results of Cenobamate Tablets 12.5 mg and Phase III clinical trial protocol of Cenobamate Tablets (12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg & 200 mg) before the committee.
Cenobamate is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.Cenobamate is used alone or with other medications to treat certain types of partial onset seizures (seizures that involve only one part of the brain) in adults
Cenobamate (CNB) is thought to have a dual mechanism of action acting on sodium channels and GABAA receptors at a non‐benzodiazepine site. Adjunctive CNB was associated with higher rates of seizure response and seizure freedom than usually seen in regulatory trials.
At the recent SEC meeting for Neurology and Psychiatry held on 16th July 2025, the expert panel reviewed the BE study results of Cenobamate Tablets 12.5 mg and Phase III clinical trial protocol of Cenobamate Tablets (12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg & 200 mg) before the committee.
After detailed deliberation, the committee considered BE results presented by the firm and recommended for grant of permission to conduct Phase III clinical trial as per the protocol presented by the firm subject to the condition that firm should include detailed safety evaluation of subjects and causality assessment of adverse drug reactions in the protocol.
