Include diagnostic criteria for Postherpetic neuralgia, neuropathic Pain: CDSCO panel tells Sun Pharma on Gabapentin study
New Delhi: Citing that specific diagnostic criteria for Postherpetic neuralgia (PHN) and neuropathic pain as per international guidelines should be included in the study protocol, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the drug major Sun Pharma's proposal to conduct the Phase IV clinical trial of Gabapentin extended released (ER) Tablets 300mg and 600mg.
In addition, the expert panel stated that psychological problems/disorders of patients should be mentioned in the exclusion criteria.
This came after Sun Pharma presented a proposal for a grant of permission to conduct a Phase IV clinical trial of Gabapentin ER Tablets 300mg and 600mg along with a Phase IV clinical trial protocol before the committee.
Gabapentin is in a class of medications called anticonvulsants. Gabapentin treats seizures by decreasing abnormal excitement in the brain. Gabapentin relieves the pain of PHN by changing the way the body senses pain. It is not known exactly how gabapentin works to treat restless legs syndrome.
Gabapentin is used to treat epilepsy. It's also taken for nerve pain, which different conditions, including diabetes and shingles, can cause. Nerve pain can also happen after an injury. In epilepsy, it's thought that gabapentin stops seizures by reducing the abnormal electrical activity in the brain.
Gabapentin modulates the action of the GABA synthetic enzyme, glutamic acid decarboxylase (GAD), and the glutamate-synthesizing enzyme, branched-chain amino acid transaminase. Results with human and rat brain NMR spectroscopy indicate that gabapentin increases GABA synthesis.
At the recent SEC meeting for Neurology and Psychology held on 12th October 2023, the expert panel reviewed the proposal presented by the drug major Sun Pharma for a grant of permission to conduct a Phase IV clinical trial of Gabapentin ER Tablets 300mg and 600mg.
After detailed deliberation, the Committee recommended the grant of permission to conduct the Phase IV clinical trial study as per the protocol presented by the firm subject to the following conditions:
1. Specific diagnostic criteria for PHN and neuropathic pain as per international guidelines should be included in the study protocol.
2. Psychological problem/disorder patients should be mentioned in the exclusion criteria.
