Eris Lifesciences Secures CDSCO Panel Nod to Conduct BE Study on Dapagliflozin, Pioglitazone, Metformin FDC
New Delhi: Eris Lifesciences has got the go ahead from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) for conducting the bioequivalence (BE) study of the fixed dose combination of oral hypoglycemic drug, Dapagliflozin Propanediol eq. to Dapagliflozin 10 mg + Pioglitazone Hydrochloride IP eq. to Pioglitazone 15 mg + Metformin Hydrochloride IP (sustained release) 1000 mg film coated bilayered tablet.
This came after the firm presented the proposal along with BE study protocol and justification for clinical trial waiver before the committee.
Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor used in the management of type 2 diabetes mellitus. Dapagliflozin inhibits the sodium-glucose cotransporter 2(SGLT2) which is primarily located in the proximal tubule of the nephron. SGLT2 facilitates 90% of glucose reabsorption in the kidneys and so its inhibition allows for glucose to be excreted in the urine. This excretion allows for better glycemic control and potentially weight loss in patients with type 2 diabetes mellitus.
Pioglitazone is a thiazolidinedione used adjunctively with diet and exercise to normalize glycemic levels in adults with type 2 diabetes mellitus. Pioglitazone is a selective agonist at peroxisome proliferator-activated receptor-gamma (PPARγ) in target tissues for insulin action such as adipose tissue, skeletal muscle, and liver. Activation of PPARγ increases the transcription of insulin-responsive genes involved in the control of glucose and lipid production, transport, and utilization. Through this mechanism, pioglitazone both enhances tissue sensitivity to insulin and reduces the hepatic production of glucose (i.e. gluconeogenesis) - insulin resistance associated with type 2 diabetes mellitus is therefore improved without an increase in insulin secretion by pancreatic beta cells.
Metformin is a biguanide antihyperglycemic used in conjunction with diet and exercise for glycemic control in type 2 diabetes mellitus. It is also used off-label for insulin resistance in polycystic ovary syndrome (PCOS). Metformin is a biguanide antihyperglycemic agent and first-line pharmacotherapy used in the management of type II diabetes. Metformin is considered an antihyperglycemic drug because it lowers blood glucose concentrations in type II diabetes without causing hypoglycemia. It is commonly described as an "insulin sensitizer", leading to a decrease in insulin resistance and a clinically significant reduction of plasma fasting insulin levels. Another well-known benefit of this drug is modest weight loss, making it an effective choice for obese patients type II diabetes.
At the recent SEC meeting for endocrinology and metabolism, the expert panel reviewed the BE study protocol and justification for clinical trial waiver presented by Eris Lifesciences.
After detailed deliberation, the committee recommended the grant of permission to conduct the BE study.
Accordingly, the expert panel suggested that the firm should submit BE study report to CDSCO for further review by the committee. In addition, it stated that decision on the Phase III clinical trial may be taken after review of BE study results.
