Synokem gets CDSCO Panel nod to study FDC Torsemide plus Eplerenone film coated tablet
New Delhi: Considering the bioequivalence (BE) report of the fixed-dose combination (FDC) Torsemide IP 10mg/ 20mg plus Eplerenone IP 25mg/25mg film-coated tablet presented by Synokem Pharmaceutical, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved to conduct the Phase III clinical trial (CT) for the proposed...
New Delhi: Considering the bioequivalence (BE) report of the fixed-dose combination (FDC) Torsemide IP 10mg/ 20mg plus Eplerenone IP 25mg/25mg film-coated tablet presented by Synokem Pharmaceutical, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved to conduct the Phase III clinical trial (CT) for the proposed drug combination.
This came after Synokem Pharmaceutical presented its proposal along with a request to reconsider the BE study report and revise the Phase III clinical trial protocol before the committee.
Eplerenone plus Torasemide is primarily used to remove excess water from the body. It also maintains the bloodstream's potassium level and prevents hypertension (high blood pressure) due to edema (fluid retention).
Torsemide belongs to the pyridine-sulfonylurea class of loop diuretics. Its primary site of activity is the thick ascending limb of the loop of Henle, where it blocks active reabsorption of sodium and chloride, resulting in diuresis, natriuresis, and other effects.
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.
Eplerenone is an aldosterone receptor antagonist used to improve the survival of patients with symptomatic heart failure and to reduce blood pressure. Eplerenone binds to the mineralocorticoid receptor and thereby blocks the binding of aldosterone (a component of the renin-angiotensin-aldosterone-system, or RAAS).
Eplerenone is a blood pressure medicine. It is used to treat heart failure and reduce the risk of having other heart problems or a stroke. It also helps to stop heart failure from getting worse. It can sometimes be used to treat a condition called hyperaldosteronism.
At the recent SEC meeting for Cardiovascular held on 9th January 2024, the expert panel reviewed the proposal presented by the drug major Synokem Pharmaceutical regarding the Phase III clinical trial of the fixed-dose combination (FDC) Torsemide IP 10mg/ 20mg plus Eplerenone IP 25mg/25mg film-coated tablet.
After detailed deliberation, the committee considered a BE report and recommended a grant of permission to conduct the Phase III CT study.
Accordingly, the expert panel suggested that the firm should submit a Phase III CT study report to CDSCO for review by the committee.
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