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.
Brivaracetam is also an antiepileptic medication. It works by attaching itself to specific sites (SV2A) on the surfaces of nerve cells. This suppresses the abnormal activity of the nerve cells in the brain and prevents the spread of electrical signals that cause seizures.
Brivaracetam is used alone and in combination with other medications to control partial onset seizures (seizures that involve only one part of the brain) in adults, children, and infants 1 month of age and older.
At the recent SEC meeting for Neurology & Psychiatry held on 15th February 2023, the expert panel reviewed the proposal presented by the drugmaker Hetero Labs along with BE & Phase III clinical trial protocol of FDC Lacosamide plus Brivaracetam.
After detailed deliberation, the committee recommended that :
1. There is no unmet need for the proposed FDC.
2. The product is not approved internationally.
3. There is no scientific literature available from good indexed journals/peer-reviewed journals in support of the proposed FDC.
4. The firm could not justify the scientific rationale.
5. The firm did not inform the adverse effect profile.
In view of the above, the committee suggested the firm to submit the justification to CDSCO for further review by the committee.
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