Last Updated on August 13, 2024 by The Health Master
CDSCO
Sun Pharmaceutical Industry has received approval from the Central Drugs Standard Control Organisation (CDSCO) to conduct a bioequivalence study for its proposed drug, Fexuprazan Hydrochloride.
This groundbreaking development comes after the company presented a comprehensive proposal to the Subject Expert Committee (SEC) outlining the manufacturing and marketing plans for the drug.
Fexuprazan: A Potential Game-Changer
Fexuprazan Hydrochloride is a novel potassium-competitive acid blocker (P-CAB) designed to treat erosive esophagitis (EE), a painful condition caused primarily by gastroesophageal reflux disease (GERD).
Unlike traditional proton pump inhibitors (PPIs), P-CABs offer a unique mechanism of action that effectively reduces stomach acid production.
Key symptoms of erosive esophagitis include:
- Heartburn
- Regurgitation
- Epigastric pain
- Difficulty swallowing (dysphagia)
- Painful swallowing (odynophagia)
- Nausea
- Chronic cough
- Dental erosion
- Laryngitis
- Asthma
These symptoms can significantly impact a person’s quality of life and daily activities.
How Does Fexuprazan Work?
Fexuprazan works by reversibly blocking the K+/H+-ATPase enzyme in the stomach, preventing acid production.
Clinical trials have shown promising results, demonstrating comparable efficacy to PPIs in healing erosive esophagitis and relieving GERD-related symptoms without compromising safety.
Ongoing research is exploring the potential benefits of fexuprazan in treating:
- NSAID-induced peptic ulcer disease
- Non-erosive GERD
- Acute and chronic gastritis
- Maintaining the healing of erosive esophagitis
SEC Approves Bioequivalence Study
The SEC, a panel of experts under CDSCO, carefully evaluated Sun Pharma’s proposal and granted permission to proceed with the bioequivalence study.
This essential step is crucial in determining the drug’s safety and efficacy before it can be launched in the market.
Sun Pharma’s successful approval is a significant milestone in the development of Fexuprazan Hydrochloride, offering hope to millions of patients suffering from erosive esophagitis and related conditions.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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