Eris Lifescience gets CDSCO panel nod to study FDC of Metoprolol Succinate, Dapagliflozin
New Delhi: Directing to present bioequivalence (BE) study results in the Subject Expert Committee (SEC) before initiating the Phase III clinical trial, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted approval to drug maker Eris for conducting bioequivalence (BE) study and Phase III clinical trial of the fixed-dose combination drug Metoprolol Succinate plus Dapagliflozin.
This came after the firm presented its proposal along with BE and Phase III CT protocol.
Metoprolol is in a class of medications called beta blockers. It works by relaxing blood vessels and slowing heart rate to improve blood flow and decrease blood pressure. Metoprolol is used alone or in combination with other medications to treat high blood pressure. It also is used to prevent angina (chest pain) and to improve survival after a heart attack. Metoprolol also is used in combination with other medications to treat heart failure.
Dapagliflozin is in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It lowers blood sugar by causing the kidneys to get rid of more glucose in the urine. By inhibiting SGLT2, dapagliflozin blocks reabsorption of filtered glucose in the kidney, increasing urinary glucose excretion and reducing blood glucose levels. Its mechanism of action is independent of pancreatic β cell function and modulation of insulin sensitivity.
After detailed deliberation, the committee recommended the grant of permission to conduct the proposed BE and Phase III CT with the condition that BE study results should be presented in the SEC before initiating the Phase III CT.
