Submit Revised CT Protocol of FDC Gabapentin,Lidocaine Gel: CDSCO panel tells Akums Drugs
New Delhi: Reviewing the justification and Phase III clinical trial protocol presented by the drug-maker Akums Drugs & Pharmaceuticals for the fixed-dose combination drug Gabapentin USP 6.0% w/w plus Lidocaine HCl IP, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined that the firm should submit the revised Phase III clinical trial protocol with respect to exclusion criteria, sample size, rescue medication, etc.
This came after the firm presented the proposal along with justification and the Phase III CT protocol, Gabapentin USP 6.0% w/w plus Lidocaine HCl IP eq. to Lidocaine 5.0% w/w Gel, before the Committee.
The fixed-dose combination drug, Gabapentin USP 6.0% w/w plus Lidocaine HCl IP is used to treat neuropathic pain.
Gabapentin is an anticonvulsant medication used in the management of peripheral neuropathic pain, postherpetic neuralgia, and partial-onset seizures. Gabapentin crosses several lipid membrane barriers via system L amino acid transporters. In vitro, gabapentin modulates the action of the GABA synthetic enzyme, glutamic acid decarboxylase (GAD) and the glutamate synthesizing enzyme, branched-chain amino acid transaminase.
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.
