CDSCO Panel rejects Torrent proposal To Waive BE Study of FDC Gabapentin plus Duloxetine
New Delhi: Rejecting the proposal for the bioequivalence (BE) study waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined Torrent Pharmaceutical to conduct the BE study for the fixed-dose combination (FDC) Gabapentin (100mg/200mg/300mg/400mg/400mg) plus Duloxetine Hydrochloride (As enteric coated pellets)...
New Delhi: Rejecting the proposal for the bioequivalence (BE) study waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined Torrent Pharmaceutical to conduct the BE study for the fixed-dose combination (FDC) Gabapentin (100mg/200mg/300mg/400mg/400mg) plus Duloxetine Hydrochloride (As enteric coated pellets) 20mg/20mg/20mg/20 mg/30mg hard gelatin capsule.
This came after the drug major Torrent Pharmaceutical presented its proposal along with a request for a BE study waiver and Phase III 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 can be caused by different conditions, including diabetes and shingles. 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.
Duloxetine belongs to a group of medicines known as selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). These medicines are thought to work by increasing the activity of chemicals called serotonin and norepinephrine in the brain.
Duloxetine is used to treat depression and anxiety. It is also used for pain caused by nerve damage associated with diabetes (diabetic peripheral neuropathy). Duloxetine is also used to treat fibromyalgia (muscle pain and stiffness) and chronic (long-lasting) pain that is related to muscles and bones.
At the recent SEC meeting for Neurology and Psychiatry held on 15th February 2024, the expert panel reviewed the proposal along with a request for a BE study waiver and Phase III clinical trial protocol of the FDC Gabapentin plus Duloxetine Hydrochloride hard gelatin capsule.
After detailed deliberation, the committee did not consider the request for a BE study waiver and recommended the conduct of the BE study with the proposed FDC.
Accordingly, the expert panel suggested that the firm should submit the BE study protocol to CDSCO for review. Furthermore, the committee stated that the decision on the Phase III clinical trial protocol may be taken after a review of the BE study results.
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