Synokem gets CDSCO Panel nod to market Topiroxosatat
New Delhi: Pharmaceutical major Synokem Pharmaceutical has got a green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market Topiroxosatat Tablet 20/40/60 mg.
This came after the firm presented a proposal for permission to manufacture and market the Topiroxosatat Tablets 20/40/60 mg along with bioequivalence study results.
Topiroxostat, a selective xanthine oxidase inhibitor, shows effective reduction in the serum urate level in hyperuricemic patients with or without gout.
It is developed for the treatment and management of hyperuricemia and gout. Xanthine oxidase inhibitors are classified into two groups, purine analogs such as Allopurinol and Oxypurinol, and non-purine agents which include topiroxostat. Topiroxostat reduces the synthesis of uric acid by competitively inhibiting xanthine oxidase in a selective and time-dependent manner. It helps to reduce the concentration of insoluble urates and uric acid in tissues, plasma, and urine.
Xanthine oxidase, or xanthine oxidoreductase, regulates purine metabolism. The inhibition of the enzyme results in an efficacious reduction of serum urate levels. Topiroxostat covalently binds to and inhibits, molybdenum- pterin, the active center of xanthine oxidase. It also shows properties of inhibition of ATP-binding cassette transporter G2 (ABCG2) in vitro, which is a membrane protein responsible for recovering uric acid in the kidneys and secreting uric acid from the intestines.
Earlier, at the 69th SEC meeting for Reproductive and Urology, in response to the proposal for a clinical trial (CT) waiver along with the bioequivalence (BE) study protocol presented by the drug maker Synokem, the expert panel noted that Topiroxostat tablets 20mg, 40mg, and 60mg are already approved in the country and agreed with the justification submitted for CT waiver and recommended for grant of permission to conduct the BE study as per the protocol presented subject to the condition that the reference arm of the bioequivalence study should be Topiroxostat 60mg tablets only.
Now, in continuation, at the recent SEC meeting for Reproductive and Urology held on July 27,2022, the expert panel reviewed the proposal presented by the firm for permission to manufacture and market the Topiroxosatat.
After detailed deliberation, the committee noted that the drug Topiroxosatat is already approved in the country and opined that the Topiroxosatat Tablet 60mg of Synokem Pharmaceuticals and the reference Topiroxosatat Tablet 60 mg are bioequivalent.
Hence, the committee recommended the grant of permission to manufacture and market Topiroxosatat Tablets 20/40/60 mg.