Conduct phase 3 trail of Esomeprazole Gastro-resistant Tablets: CDSCO panel tells Sun Pharma

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Organization (CDSCO) has recommended Sun Pharma to conduct a Phase III Clinical Trial with Esomeprazole dual-release gastro-resistant tablets 80 mg vs Esomeprazole gastro-resistant tablets 40mg bid for the proposed indication.

This recommendation came in the wake of the proposal of Esomeprazole dual-release gastro-resistant Tablets 80 mg along with the results of a bioequivalence (BE) study presented by the pharmaceutical major Sun Pharma.

Esomeprazole is a proton pump inhibitor which is used to treat gastroesophageal reflux disease (GERD), reduce the risk of non steroidal anti inflammatory drug (NSAID) associated gastric ulcers, eradicate H. pylori, and treat conditions causing gastric acid hypersecretion.

Esomeprazole exerts its stomach acid-suppressing effects by preventing the final step in gastric acid production by covalently binding to sulfhydryl groups of cysteines found on the (H+, K+)-ATPase enzyme on the secretory surface of gastric parietal cells. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. 

Sun Pharma marketed esomeprazole 40 mg under the brand names Sompraz 40mg Tab, Raciper-40mg Tab. Apart from this, some popular brands of esomeprazole 40 mg include Glenmark's Esoz Fast 40mg Tablet, Cipla's Esomac 40 Mg Injection, Torrent Pharma's Nexpro 40mg Injection, Cadila Pharma's Espra-40mg Tab, etc.

At the 39th SEC meeting for Gastroenterology & Hepatology held on 18.08.2021 at CDSCO, the committee thoroughly examined the proposal presented by the drug-maker Sun Pharma.

After detailed deliberation, the committee opined that the firm should conduct a Phase III Clinical trial with Esomeprazole dual-release gastro-resistant tablets 80 mg vs Esomeprazole gastro-resistant tablets 40mg bid for the proposed indication.

Accordingly, the committee further stated that the firm should submit a clinical trial protocol for review by the committee.