India's drug regulatory panel has granted Sun Pharma Laboratories approval to manufacture and market Fexuprazan Hydrochloride 40mg tablets, expanding treatment options for patients with erosive esophagitis. The Subject Expert Committee (SEC) under the Central Drug Standard Control Organisation (CDSCO) made this decision following a comprehensive review of clinical data.
Clinical Evidence and Trial Results
The approval was based on a robust Phase III clinical trial program that demonstrated Fexuprazan's efficacy through a randomized, multi-centric, double-blind study comparing it with esomeprazole. Additionally, bioequivalence studies confirmed the drug's comparability to the original formulation manufactured by Daewoong Pharmaceutical Co., Ltd., South Korea.
Fexuprazan represents a new class of gastric acid suppressants known as potassium-competitive acid blockers (P-CABs). The drug works by reversibly inhibiting the K+/H+-ATPase enzyme in gastric parietal cells, maintaining acid suppression for 24 hours in a dose-dependent manner.
Treatment Impact and Disease Context
Erosive esophagitis, primarily caused by gastroesophageal reflux disease (GERD), involves erosion of the esophageal epithelium due to chronic irritation. Patients typically experience symptoms including heartburn, regurgitation, epigastric pain, and difficulty swallowing, which can significantly impact quality of life.
Clinical trials have shown Fexuprazan's comparable efficacy to proton pump inhibitors (PPIs) in healing erosive esophagitis and alleviating GERD-related symptoms, with a favorable safety profile. The drug is currently under investigation for additional indications, including NSAID-induced peptic ulcer prevention and non-erosive GERD treatment.
Regulatory Requirements and Market Access
The CDSCO approval comes with specific conditions that Sun Pharma must meet:
- Implementation of an active post-marketing surveillance (PMS) study, with the protocol to be submitted to CDSCO within three months
- Distribution restricted to prescription-only sales through registered medical practitioners
This regulatory milestone follows the drug's existing approval in South Korea, where it has demonstrated successful outcomes in treating erosive esophagitis. The introduction of Fexuprazan in India represents a significant advancement in the treatment landscape for acid-related gastrointestinal disorders.
