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Pure and Cure Healthcare Gets CDSCO Panel Nod To study Pregabalin, Duloxetine, Methylcobalamin FDC

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-11-02T17:45:20+05:30  |  Updated On 2 Nov 2024 5:45 PM IST
Pure and Cure Healthcare Gets CDSCO Panel Nod To study Pregabalin, Duloxetine, Methylcobalamin FDC
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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.

Also Read: AstraZeneca Gets CDSCO Panels Nod to study anticancer drug AZD0901

Pure & Cure HealthcarecdscopregabalinDuloxetinemethylcobalamin
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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