CDSCO Panel Tells Synokem to conduct phase 3 CT of antidiabetic FDC drug

Written by Dr. Divya Colin Published On 2023-02-05T18:00:05+05:30 | Updated On 5 Feb 2023 6:00 PM IST

CDSCO Panel Tells Synokem to conduct phase 3 CT of antidiabetic FDC drug

New Delhi: Highlighting that there is no sufficient data, no unmet need & and FDC is not approved the drug internationally, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Synokem Pharma to conduct a Phase III clinical trial (CT) of the antidiabetic fixed-dose combination drug Teneligliptin hydrobromide hydrate plus Metformin hydrochloride (SR) IP plus Dapagliflozinpropanediol monohydrate.

In respect of bioequivalence study waiver, the expert panel approves the request of the drug major Synokem Pharma. This came after the firm presented its proposal along with justification for bioequivalence study (BE) and clinical trial (CT) Study waiver.

Teneligliptin belongs to the class of anti-diabetic drugs known as dipeptidyl peptidase-4 inhibitors or gliptins. It is indicated for the management of type 2 diabetes mellitus (T2DM) in adults along with diet and exercise. Teneligliptin is currently used in cases showing insufficient improvement in glycemic control even after diet control and exercise or a combination of diet control, exercise, and sulfonylurea- or thiazolidine-class drugs.

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 decreases blood glucose levels by decreasing hepatic glucose production (also called gluconeogenesis), decreasing the intestinal absorption of glucose, and increasing insulin sensitivity by increasing peripheral glucose uptake and utilization.

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. It inhibits the sodium-glucose cotransporter 2(SGLT2) which is primarily located in the proximal tubule of the nephron. SGLT2 facilitates 90% of glucose resorption in the kidneys and so its inhibition allows for glucose to be excreted in the urine.

Together, the fixed drug combination of Teneligliptin, Metformin hydrochloride and Dapagliflozin provides better control of blood sugar.

At the recent SEC meeting for Endocrinology & Metabolism held on 19th and 20th January 2023, the expert panel reviewed the proposal presented by Synokem Pharmaceuticals along with justification for BE and CT Study waiver of the FDC drug Teneligliptin hydrobromide hydrate plus Metformin hydrochloride (SR) IP plus Dapagliflozinpropanediol monohydrate.

After detailed deliberation, the committee considered the request of the firm for BE study waiver.

However, with regard to the Phase III CT Study waiver, the committee noted that:

The FDC is not approved internationally.
Insufficient data presented by the firm.
There is no unmet need.

In view of the above observation, the committee reiterated its recommendation dated 18.03.2021 & 19.03.2021 with respect to Phase III CT Study. Accordingly, the expert panel directed that the firm should conduct the Phase III CT Study after taking NOC from CDSCO.

Also Read:Synokem Pharmaceuticals gets CDSCO panel nod to conduct phase III CT of FDC Salicylic Acid plus Luliconazole

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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.