Torrent Pharmaceutical gets CDSCO Panel nod to study Gabapentin plus Duloxetine FDC
New Delhi: Torrent Pharmaceuticals has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the bioequivalence (BE) study of the fixed-dose combination (FDC) Gabapentin (100mg /200mg /300mg /400mg/ 400mg) plus Duloxetine Hydrochloride (as enteric coated pellets) 20 mg/20 mg/20 mg/20 mg/30 mg hard gelatin capsule.
This came after Torrent Pharmaceuticals presented the proposal along with the BE study protocol for the fixed-dose combination (FDC) Gabapentin plus Duloxetine Hydrochloride (as enteric-coated pellets) hard gelatin capsule before the committee.
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; now, it is also widely used to treat neuropathic pain.
Duloxetine is a serotonin-norepinephrine reuptake inhibitor used to treat generalized anxiety disorder, neuropathic pain, osteoarthritis, and stress incontinence. 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, the expert panel reviewed the proposal along with the BE study protocol for the fixed-dose combination (FDC) of Gabapentin plus Duloxetine Hydrochloride (as enteric-coated pellets) hard gelatin capsule presented by Torrent Pharmaceuticals.
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After detailed deliberation, the committee granted permission to conduct the BE study.
However, the expert panel suggested that the firm should submit the BE study report along with Phase III CT protocol to CDSCO for review by the committee.
