Pure and Cure Healthcare Gets CDSCO Panel Nod To study Pregabalin, Duloxetine, Methylcobalamin FDC
New Delhi: Pure and Cure Healthcare has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the bioequivalence study and Phase III clinical trial study of the fixed-dose combination (FDC) of Pregabalin (as granules) plus Duloxetine Hydrochloride (as delayed-release pellets) plus Methylcobalamin (as granules).
This came after the firm presented the proposal along with the bioequivalence (BE) study and Phase III clinical trial protocol.
Pregabalin is an anticonvulsant drug used to treat neuropathic pain conditions and fibromyalgia and for the treatment of partial onset seizures in combination with other anticonvulsants. Pregabalin is structurally similar to gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter. It may be used to manage neuropathic pain, postherpetic neuralgia, and fibromyalgia, among other conditions. Although, as per the FDA, the mechanism of action has not been definitively characterized, there is evidence that pregabalin exerts its effects by binding to the α2δ subunit of voltage-dependent calcium channels.
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