Akum Drugs & Pharmaceutical gets CDSCO Panel nod for BE study of FDC Eplerenone plus Torsemide film-coated tablet

However, regarding the Phase III clinical trial protocol, the committee opined that total study duration should be 24 weeks, and patients on diuretics other than mineralocorticoid receptor antagonists should be removed from the exclusion criteria.

Eplerenone is in a class of medications called mineralocorticoid receptor antagonists. It works by blocking the action of aldosterone, a natural substance in the body that raises blood pressure. Eplerenone is used alone or in combination with other medications to treat high blood pressure.

Torsemide is used to help treat fluid retention (edema) and swelling that is caused by congestive heart failure, liver disease, and kidney disease. It belongs to the group of medicines called loop diuretics (water pills). This medicine works by acting on the kidneys to increase the flow of urine.

At the recent SEC meeting for cardiovascular held on November 19, 2024, the expert panel reviewed the proposal along with the BE protocol and Phase III clinical trial protocol before the committee.

After detailed deliberation, the committee recommended conducting the BE Study. As regards the Phase III clinical trial protocol, the committee opined that:

1. Total study duration should be 24 weeks.

2. “Patients on diuretics other than mineralocorticoid receptor antagonists should be removed from the exclusion criteria.

Accordingly, the expert panel suggested that the BE study reports should be submitted along with the revised Phase III clinical trial protocol to CDSCO for further review by the committee.

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