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

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.

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