Conduct BE study with innovator drug as reference product: CDSCO Panel Tells Synokem on FDC Torsemide plus Eplerenone
New Delhi: After reviewing the bioequivalence (BE) study report presented by Synokem Pharmaceutical for the fixed-dose combination Torsemide IP 10mg/20mg plus Eplerenone IP 25mg/25mg film-coated tablet, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended that the firm should conduct BE study with individual innovator drugs as a reference product and submit the BE protocol to the committee.
This came after Synokem Pharmaceutical presented its proposal and a BE study report before the committee.
The committee noted that the firm has not conducted the BE study with individual innovator drugs as a reference product.
Torsemide 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. 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 belongs to the general class of medicines called antihypertensives. It is used alone or with other medicines to treat high blood pressure (hypertension). This medicine is also used to treat congestive heart failure (CHF) after a heart attack.
Eplerenone selectively binds to the mineralocorticoid receptor, thereby blocking the binding of aldosterone and thus inhibiting sodium reabsorption and other deleterious aldosterone-mediated mechanisms.
At the SEC meeting for Cardiovascular and Renal held on 22nd November 2023, the expert panel reviewed the proposal presented by the drug major Synokem Pharmaceutical along with the BE study report of the FDC Torsemide plus Eplerenone film coated table.
The committee took note of the fact that the company had not used specific innovative medications as a reference product in the BE study.
After detailed deliberation, the committee recommended that the firm should conduct a BE study with individual innovator drugs as a reference product.
Accordingly, the expert panel suggested that the firm should submit the BE protocol to CDSCO for further review.
