Submit justification: CDSCO Panel tells Hetero for FDC Lacosamide, Brivaracetam

New Delhi: In line with the drug maker Hetero Pharma's proposal for the fixed-dose combination Lacosamide plus Brivaracetam, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit the justification in respect to the combination drug to the CDSCO for further review by the committee.
This came after the drug maker Hetero Pharma presented its proposal along with bioequivalence (BE) and Phase III clinical trial protocol before the committee.
Lacosamide is an antiepileptic drug used to treat partial-onset seizures in adults. It is proposed that lacosamide's inhibition of sodium channels is responsible for analgesia.
Lacosamide may be selective for inhibiting depolarized neurons rather than neurons with normal resting potentials. Pain and nociceptor hyperexcitability are associated with neural membrane depolarization. Lacosamide binds to collapsin response mediator protein-2 (CRMP-2), a phosphoprotein which is expressed primarily in the nervous system and is involved in neuronal differentiation and control of axonal outgrowth. The role CRMP-2 of binding in seizure control hasn't been elucidated.
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