Synokem Pharma Gets CDSCO Panel Nod To Study Antidiabetic FDC
New Delhi: The drug major Synokem Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the bioequivalence (BE) study of the fixed-dose combination (FDC) antidiabetic drug Empagliflozin plus Sitagliptin Phosphate Monohydrate plus Metformin Hydrochloride.
However, the approval is subject to the condition that the doctor (MD Medicine) should be present during the study.
This came after the drug maker Synokem Pharmaceutical presented its proposal for the BE study protocol and Phase III clinical trial protocol before the committee.
Empagliflozin 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. Empagliflozin works by inhibiting the sodium-glucose co-transporter-2 (SGLT-2) found in the proximal tubules in the kidneys. Through SGLT2 inhibition, empagliflozin reduces renal reabsorption of glucose and increases urinary excretion of glucose. The glucose-lowering effect of the drug is independent of insulin.
Sitagliptin belongs to a class of drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors. Inhibition of DPP-4 by sitagliptin slows DPP-4-mediated inactivation of incretins like GLP-1 and GIP. Incretins are released throughout the day and upregulated in response to meals as part of glucose homeostasis. Reduced inhibition of incretins increases insulin synthesis and decreases glucagon release in a manner dependent on glucose concentrations. These effects lead to an overall increase in blood glucose control which is demonstrated by reduced glycosylated hemoglobin (HbA1c).
Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in the blood. It decreases the amount of glucose absorbed from food and the amount of glucose made by the liver.
At the recent SEC meeting for endocrinology and metabolism held on 24th January 2023, the expert panel reviewed the proposal presented with the BE study protocol and Phase III clinical trial protocol of the FDC antidiabetic drug.
After detailed deliberation, the committee recommended the grant of permission to conduct the BE study with the condition that a doctor (MD Medicine) should be present during the study.
Accordingly, the expert panel suggested that the firm should submit a BE study report for review by the committee to make further decisions on the Phase III clinical trial protocol.
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