Synokem Gets CDSCO Panel Nod To Manufacture, Market antidiabetic FDC Pioglitazone, Vildagliptin
New Delhi: With the condition of conducting phase IV clinical trial, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has given its nod to the drug major Synokem Pharmaceutical for manufacturing and marketing the antidiabetic fixed-dose combination (FDC) drug Pioglitazone plus Vildagliptin film coated bilayered tablet.
This came after Synokem Pharmaceutical presented the clinical trial report of Pioglitazone plus Vildagliptin (30mg/100mg +15mg/100mg) film-coated bilayered tablet, before the committee. The committee noted that the firm has already presented a bioequivalence (BE) study report in the SEC meeting held on 09.09.2022.
Vildagliptin is used to control blood sugar levels in patients with type 2 diabetes mellitus. It is used along with diet and exercise to improve blood sugar control in adults with type 2 diabetes. Vildagliptin is an antidiabetic medication.
Vildagliptin binds covalently to the catalytic site of DPP-4, eliciting prolonged enzyme inhibition. This raises intact GLP-1 levels, both after meal ingestion and in the fasting state. Vildagliptin has been shown to stimulate insulin secretion and inhibit glucagon secretion in a glucose-dependent manner.
Pioglitazone is used with proper diet and exercise to treat high blood sugar levels caused by type 2 diabetes. Pioglitazone improves glycaemic control in people with Type 2 diabetes by improving insulin sensitivity through its action at PPAR gamma 1 and PPAR gamma 2 and affects lipid metabolism through action at PPAR alpha.
At the recent SEC meeting for Endocrinology and Metabolism held on the 22nd and 23rd of August 2023, the expert panel reviewed the clinical trial report of Pioglitazone plus Vildagliptin (30mg/100mg +15mg/100mg) film-coated bilayered tablet presented by Synokem Pharmaceutical.
The committee took note of the fact that the firm had previously presented a bioequivalence (BE) study report to the SEC meeting on September 9, 2022.
The committee also noted that the clinical trial study was conducted in low-risk individuals and small sample size.
After detailed deliberation, the committee recommended the grant of permission for manufacturing and marketing of the proposed FDC, subject to the condition that the firm should conduct the Phase IV clinical trial.
Accordingly, the expert panel suggested that the firm should submit the Phase IV clinical trial protocol to CDSCO within 03 months of approval for review by the committee.
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