Akums gets CDSCO Panel nod to study Gabapentin, Lidocaine FDC gel
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has given its approval to the drug major Akum Pharmaceutical to conduct the Phase III clinical trial of the fixed-dose combination (FDC) Gabapentin USP plus Lidocaine HCl IP eq. to Lidocaine Gel.
This came after Akum Pharmaceutical presented the comparative chart before the committee after incorporating the suggested points in the revised protocol.
Gabapentin plus lidocaine hydrochloride is a combination medicine used to treat neuropathic pain. Neuropathic pain is a chronic progressive nerve disease that causes nerve pain due to a damaged or malfunctioning nervous system.
Gabapentin is an anticonvulsant medication used in the management of peripheral neuropathic pains, postherpetic neuralgia, and partial-onset seizures. Gabapentin is a structural analog of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). It was originally developed as a novel anti-epileptic for the treatment of certain types of seizures.
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 an anesthetic of the amide group indicated for the production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks.
At the recent SEC meeting for Neurology and Psychiatry held on 17th August 2023, the expert panel reviewed the proposal and revised protocol presented by Akum Pharmaceutical regarding Gabapentin plus Lidocaine HCl Gel.
After detailed deliberation, the committee recommended the grant of permission to conduct the Phase III clinical trial study. Furthermore, the expert panel suggested that the firm should submit the Phase III clinical trial report for review by the SEC.
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