MSN Lab Gets CDSCO Panel Nod To Manufacture, Market Vigabatrin Powder for Oral Solution

This came after the drug major MSN Laboratories presented the proposal for manufacturing and marketing Vigabatrin powder for oral solution USP- 250mg/sachet for already approved indication along with therapeutic rationale and bioequivalence (BE) study/clinical trial waiver justifications, before the committee.

Vigabatrin is an analog of gamma-aminobutyric acid (GABA), the main inhibitory neurotransmitter in the central nervous system, used in the treatment of refractory seizures and infantile spasms. It irreversibly inhibits the enzyme responsible for GABA metabolism, thereby increasing levels of circulating GABA.

Vigabatrin is indicated as adjunctive therapy in the treatment of refractory complex partial seizures in patients 2 years of age and older who have had inadequate responses to multiple previous treatments (i.e. not to be used for first-line therapy).

It is also indicated as monotherapy in the treatment of infantile spasms in patients between 1 month and 2 years of age for whom the potential benefits outweigh the risk of vision loss.

Vigabatrin is an irreversible inhibitor of gamma-amino-butyric acid transaminase (GABA-T), an enzyme that degrades GABA. It is structurally the same as GABA with an extra vinyl group. Given this fact, it acts as a substrate for GABA-T, setting GABA free in the synaptic cleft.

Gamma-aminobutyric acid (GABA) is the major inhibitory transmitter throughout the central nervous system, and the potentiation of GABAergic neurotransmission is, therefore, a crucial mechanism through which antiepileptic agents may combat the pathologic excitatory neurotransmission seen in epilepsy.

Vigabatrin increases concentrations of GABA in the central nervous system by irreversibly inhibiting the enzymes responsible for its metabolism to succinic semialdehyde: gamma-aminobutyric acid transaminase (GABA-T).

At the recent SEC meeting for Neurology and Psychiatry held on 13th June 2023, the expert panel reviewed the proposal for manufacturing and marketing of Vigabatrin powder for oral solution USP- 250mg/sachet for already approved indication along with therapeutic rationale and BE study/clinical trial waiver justifications.

The committee noted that the higher strength of Vigabatrin powder for oral solution USP 500mg/sachet is already approved in India for the following indications:

1. “For the treatment of refractory complex partial seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; Vigabatrin powder for oral Solution, USP, 500 mg is not indicated as a first-line agent”.

2. “Infantile spasms - monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss”

Furthermore, the committee considered BE study/clinical trial waiver based on the justification presented by the firm.

After detailed deliberation, the committee recommended the grant of permission to manufacture and market Vigabatrin powder for oral solution USP 250mg/sachet for already approved indication.

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