Include more government sites in Febuxostat ER tablet trial: CDSCO Panel Nod tells Akums Drugs
New Delhi: Stating to include more government sites in the trial, the drug major Akum Pharma has got a green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the Phase III clinical trial of the Febuxostat extended-release (ER) tablet 40/80mg.
This recommendation is subject to the condition that the firm should add more government sites for the study.
This came after the drug major Akum Pharma presented the Phase III clinical trial protocol of Febuxostat.
Febuxostat is a medication used to manage and treat hyperuricemia and gout. It is in a class of drugs known as xanthine oxidase inhibitors. Febuxostat works by inhibiting the activity of an enzyme that is responsible for the synthesis of uric acid, thereby reducing serum uric acid levels.
Febuxostat oral tablet is used to treat hyperuricemia (constantly high levels of uric acid) in adults who have gout. It helps decrease your symptoms of gout. Symptoms of gout include pain, swelling, redness, heat, soreness, and stiffness in certain joints.
At the recent SEC meeting for Reproductive and Urology held on held 25th May 2023, the expert panel reviewed the Phase III clinical trial protocol of the Febuxostat ER tablet 40/80mg
After detailed deliberation, the committee recommended the conduct of a Phase III clinical trial as per the protocol presented with the condition that more government sites should be included in the trial
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