Submit Revised CT Protocol of FDC Gabapentin,Lidocaine Gel: CDSCO panel tells Akums Drugs

Lidocaine is a local anaesthetic used in a wide variety of superficial and invasive procedures. Lidocaine can block Na+ and K+ ion channels and regulate intracellular and extracellular calcium concentrations through other ligand-gated ion channels. Lidocaine was the first sodium channel blocker to be identified. Its primary mode of action is to block voltage-gated Na+ channels (VGSC/NaVs).

At the recent SEC meeting for Neurology & Psychiatry held on December 16, 2022, the expert panel reviewed the proposal along with justification and the Phase III CT protocol of the FDC Gabapentin USP 6.0% w/w plus Lidocaine HCl IP eq. to Lidocaine 5.0% w/w Gel.

After detailed deliberation, the committee recommended that the firm submit the revised Phase III CT protocol as suggested by experts with respect to exclusion criteria, sample size, rescue medication, etc.

In accordance with the above, the expert panel directed the firm that the revised protocol should be presented before the SEC for further review.