BDR Pharma Gets CDSCO Panel Nod To Study Vonoprazan Tablets
New Delhi: The drug major BDR Pharma has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase-III clinical trial of Vonoprazan tablets 10mg/20mg.
However, this approval is subject to the condition that the firm should reassess the calculation of sample size and the clinical trial sites should be geographically distributed in the country.
This came after BDR Pharmaceuticals presented the proposal for a grant of permission for manufacturing and marketing of the drug Vonoprazan tablets 10mg/20mg along with Phase III clinical trial protocol and bioequivalence (BE) study waiver before the committee.
Vonoprazan is a potassium-competitive acid blocker used in the treatment of acid-related disorders and as an adjunct to Helicobacter pylori eradication.
Vonoprazan is a potassium-competitive acid blocker (PCAB) that inhibits the H +, K + -ATPase enzyme system in a potassium-competitive manner. Through this mechanism, vonoprazan suppresses basal and stimulated gastric acid secretion at the secretory surface of gastric parietal cells.
At the recent SEC meeting for the Gastroenterology and Hepatology held on 26 October 2023, the expert panel reviewed the proposal presented by the drug major BDR Pharmaceuticals for a grant of permission for manufacturing and marketing of the drug Vonoprazan tablets 10mg/20mg along with Phase III clinical trial protocol and BE study waiver.
After detailed deliberation, the committee recommended the grant of permission to conduct the proposed Phase-III clinical trial along with the waiver of the BE study subject to the following conditions:
1. The firm should reassess the calculation of sample size.
2. The clinical trial sites should be geographically distributed in the country.
Accordingly, the expert panel suggested that the firm should submit the revised protocol to CDSCO.
