Submit revised protocol for Ticagrelor SR tablets: CDSCO panel tells MSN Labs

New Delhi: Opining that the Phase III clinical trial protocol presented by the drug maker MSN Laboratories was inadequate with respect to title/inclusion/ exclusion /investigations criteria, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has recommended the firm to submit revised protocol to CDSCO for Ticagrelor SR Tablets 180 mg Tablet.

This came after the drug maker MSN Laboratories presented the raw data of the Bioequivalence study of Ticagrelor SR Tablets 180 mg Tablet along with Phase III clinical trial protocol.

Ticagrelor is an oral antiplatelet drug that is used with low dose aspirin to decrease the risk of myocardial infarction and stroke in patients with acute coronary syndrome. Upon oral administration, ticagrelor and its major metabolite target and reversibly bind to the platelet adenosine diphosphate (ADP) P2Y12 receptor (P2Y12R) at a site distinct from that of the endogenous agonist ADP. This blocks the platelet signaling pathway, thereby inhibiting the activation of the glycoprotein complex GPIIb/IIIa, fibrinogen binding to platelets and platelet adhesion and aggregation.

Last year, the firm presented the proposal along with Bioequivalence study report. In response, the committee recommended that the firm should present the clinical trial protocol along with raw data of the Bioequivalence study report for further review by the committee.

Accordingly, at recent SEC meeting for Cardiovascular & Renal, held on 08.02.2022 at CDSCO, the expert panel extensively evaluated the raw data of the Bioequivalence study of Ticagrelor SR Tablets 180 mg Tablet along with Phase III clinical trial protocol presented by drug maker MSN Laboratories.

After extensive evaluation, the committee opined that the Phase III clinical trial protocol presented by the firm was inadequate with respect to title/inclusion/ exclusion /investigations criteria. 

Finally, the committee recommended that the firm should submit revised protocol to CDSCO for further review by the committee.