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.

Duloxetine is a serotonin-norepinephrine reuptake inhibitor used to treat generalized anxiety disorder, neuropathic pain, osteoarthritis, and stress incontinence.

Methylcobalamin (MeCbl), the activated form of vitamin B12, has been used to treat some nutritional diseases, such as Alzheimer’s disease and rheumatoid arthritis. As an auxiliary agent, it exerts neuronal protection by promoting regeneration of injured nerves and antagonizing glutamate-induced neurotoxicity. Recently, several lines of evidence demonstrated that MeCbl may have potential analgesic effects in experimental and clinical studies. MeCbl improved nerve conduction, promoted the regeneration of injured nerves, and inhibited ectopic spontaneous discharges of injured primary sensory neurons.

At the recent SEC meeting for neurology and psychiatry held on October 16, 2024, the expert panel reviewed the proposal along with the BE study and Phase III clinical trial protocol.

After detailed deliberation, the committee recommended the grant of permission to conduct the proposed BE study and Phase III clinical trial study with the condition that the BE study report should be presented in the SEC meeting before initiating the Phase III clinical trial.

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