Dr. Reddy's Gets CDSCO Panel Nod to study gastric acid blocker Vonoprazan fumarate
New Delhi: In line with the bioequivalence (BE) study report, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has granted approval to drug major Dr. Reddy's Laboratories to conduct the Phase III clinical trial on the Vonoprazan fumarate, a novel class of potassium-competitive gastric acid blockers.
This came after the firm presented the proposal for grant of permission for manufacturing and marketing the drug Vonoprazan fumarate tablets 10 mg and 20 mg along with Phase III clinical trial protocol and BE study report before the committee.
Vonoprazan fumarate is used as an oral medication prescribed once daily for both treatments of gastric ulcers and the secondary prevention of gastric acid reflux.
The mechanism of action of vonoprazan is that it competes with potassium ions for the reversible inhibition of Hþ-Kþ-ATPase, whereas Proton pump inhibitors (PPIs) act by binding covalently to the gastric Hþ, Kþ-ATPase via disulfide bonds.
At the recent SEC meeting for Gastroenterology and Hepatology held on 23rd May 2023, the expert panel reviewed the proposal for grant of permission for manufacturing and marketing of the drug Vonoprazan fumarate tablets 10 mg and 20 mg along with Phase III clinical trial protocol and BE study report.
After detailed deliberation, the committee recommended the grant of permission to conduct the proposed Phase III clinical trial subject to the following conditions:
(1) Interim report on the safety of the drug at the end of 4 weeks to be submitted to check the renal function/nephrotoxicity associated with the study drug.
(2) During clinical laboratory screening, the lab reference range has to be strictly adhered but not at the discretion of the PI.
(3) During screening, tests for Serum B12 and Serum Calcium are to be included.
(4) Women of childbearing age should use contraception except Oral contraceptive pills during the study period and if any patient becomes pregnant, should report it immediately.
(5) Grade A and B symptomatic patients for GERD especially will be enrolled.
Accordingly, the expert panel suggested that the firm should submit the revised protocol to CDSCO for the grant of clinical trial permission.
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