Submit Revised protocol for Torsemide ER tablets: CDSCO Tells Syngene

This came after the firm presented the proposal to conduct a Phase II clinical trial of Torsemide ER Tablets 24 mg along with the Phase II clinical trial protocol.

Torsemide is in a class of medications called diuretics ('water pills'). It works by causing the kidneys to get rid of unneeded water and salt from the body into the urine.

Torsemide is used alone or in combination with other medications to treat high blood pressure. Torsemide is used to treat edema (fluid retention; excess fluid held in body tissues) caused by various medical problems, including heart, kidney, or liver disease.

Torsemide causes the excretion of sodium chloride and water by inhibiting sodium and chloride reabsorption in the ascending loop of Henle and the distal collecting tubule. The effect is caused by blocking the chloride-binding site of the Na+/K+/2Cl- cotransport mechanism.

At the recent SEC meeting for Cardiovascular and Renal held on the 6th and 7th of June 2023, the expert panel reviewed the proposal to conduct of Phase II clinical trial of Torsemide ER Tablet 24mg along with the Phase II clinical trial protocol.

After detailed deliberation, the committee opined that the protocol does not have proof of concept and criteria are not defined for the overactive bladder in CHF patients. Hence the committee did not recommend approval of the protocol in its present form.

Accordingly, the committee recommended that the firm should submit proof of concept for clinical trial along with a revised clinical trial protocol for further review by the committee.

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