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
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