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Sun Pharma Laboratories Gets CDSCO Panel Nod To Manufacture, Market Fexuprazan Hydrochloride Tablets

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-01-03T18:00:19+05:30  |  Updated On 3 Jan 2025 6:00 PM IST
Sun Pharma, Moebius Medical symptomatic knee osteoarthritis treatment MM-II
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New Delhi: Noting that Fexuprazan Hydrochloride Tablets 40 mg are approved in South Korea for treatment of erosive esophagitis, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to drug major Sun Pharma Laboratories to manufacture and market Fexuprazan Hydrochloride Tablets 40 mg.

However, this approval is subject to the condition that the firm conduct an active post-marketing surveillance (PMS) study. Furthermore, the expert panel stated that drugs should be sold by retail under the prescription of registered medical practitioners only.

This came after the firm presented Phase III clinical trial (CT) report (A Randomized, Multi-Centric, Two-Arm, Active-Controlled, Parallel, Double-Blind, Double-Dummy, Comparative Study to Evaluate Efficacy and Safety of Fexuprazan Tablets manufactured by Daewoong Pharmaceutical Co., Ltd., South Korea in Comparison to Esomeprazole Tablets manufactured by M/s. Sun Pharmaceutical Industries Ltd in Patients With Erosive Esophagitis) and bioequivalence (BE) study report (An open label,balanced, randomized, single dose, two treatments, two sequences, two periods, crossover, comparative bioavailability study of Fexuprazan Hydrochloride tablets 40 mg with Fexuclue (Fexuprazan Hydrochloride) Tablets 40 mg manufactured by Daewoong Pharmaceutical Co., Ltd., South Korea in healthy adult human subjects under fasting condition, before the committee.

The firm also presented prescribing information of an innovator product and India-specific prescribing information of the applied product Fexuprazan Hydrochloride Tablets 40 mg, before the committee.

The Committee noted that the drug Fexuprazan Hydrochloride Tablets 40 mg is approved in South Korea for treatment of erosive esophagitis (EE).

Erosive esophagitis (EE) is an erosion of the esophageal epithelium due to chronic irritation. It can be caused by a number of factors but is primarily a result of gastroesophageal reflux disease (GERD). The main symptoms of EE are heartburn and regurgitation; other symptoms can include epigastric pain, odynophagia, dysphagia, nausea, chronic cough, dental erosion, laryngitis, and asthma. Symptoms can be exacerbated by eating certain trigger foods or when lying down.

Fexuprazan is a newly developed potassium-competitive acid blocker (P-CAB), which inhibits acid generation and secretion in a competitive and reversible manner.

Fexuprazan, a novel potassium-competitive acid blocker, reversibly suppresses the K+/H+-ATPase enzyme in proton pumps within gastric parietal cells. Fexuprazan's suppression of gastric acid was maintained in healthy individuals for 24 hours in a dose-dependent manner.

Completed clinical trials of fexuprazan have demonstrated comparable efficacy to PPIs for the healing of erosive esophagitis and the relief of GERD-related esophageal symptoms without concern for safety signals. Ongoing clinical trials are evaluating fexuprazan for the prevention of NSAID-induced peptic ulcer disease, non-erosive GERD, and acute and chronic gastritis, as well as the healing efficacy and maintenance of erosive esophagitis (EE).

At the recent SEC meeting for gastroenterology and hepatology held on 12th December 2024, the expert panel reviewed the Phase III clinical trial (CT) report and bioequivalence (BE) study report of the gastric drug Fexuprazan.

After detailed deliberation, the committee recommended the grant of permission to manufacture and market the drug Fexuprazan Hydrochloride Tablets 40 mg for the proposed indication, subject to the condition that:

(a) The firm should conduct an active PMS study, for which protocol should be submitted to CDSCO within 3 months of approval for further evaluation by the committee.

(b) The drug should be sold by retail under the prescription of registered medical practitioners only.

Also Read: IQVIA Gets CDSCO Panel Nod To conduct Phase III clinical Study of Lumateperone

sun pharma labssun pharmacdscoFexuprazan HydrochlorideErosive Esophagitis
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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