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

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-12-08T17:45:06+05:30 | Updated On 8 Dec 2024 5:45 PM IST

Akums Drugs ink pact with global pharma firm

New Delhi: Akum Drugs and Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSC) to conduct the bioequivalence (BE) study of the fixed dose combination (FDC) cardiovascular drug Eplerenone plus Torsemide film-coated tablet.

This came after the firm presented the proposal along with BE protocol and Phase III clinical trial protocol before the committee.

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.

Also Read: Novartis Healthcare gets CDSCO Panel nod to study Iptacopan

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Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751