Evaluate safety in proposed study: CDSCO Panel tells Syngene on Suplatast Tosilate Capsule
New Delhi: Approving the proposal presented by Syngene International to conduct a Phase II clinical trial of Suplatast Tosilate 100mg Capsule, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined that the firm should also evaluate safety in the proposed study and submit a revised protocol to CDSCO.
This came after Syngene International presented justification or clarification for the Phase II clinical trial (CT) of the pulmonary drug Suplatast Tosilate before the committee.
Suplatast tosilate is a Th2 cytokine inhibitor that lowers the titer of the IgE antibody through specific inhibition of the production of IL (interleukin)-4 and IL-5 by T cells and inhibits tissue infiltration by eosinophils.
Suplatast tosilate is used as an antihistamine. It has been suggested and applied in the treatment of Kimura's disease a few times.
As a new antiallergic drug, suplatast tosilate modulates T-helper type 2 cell cytokine production. Oral administration of suplatast tosilate suppressed airway hyperresponsiveness in patients with asthma by reducing eosinophilic inflammation in the airways.
At the recent SEC meeting for Pulmonary held on 21 September 2023, the expert panel reviewed the justification/clarification presented by Syngene International for the Phase II clinical trial of the pulmonary drug Suplatast Tosilate.
After detailed deliberation, the committee recommended a grant of permission to conduct the Phase II study.
In addition to the above, the committee recommended that the firm should also evaluate safety in the proposed study and submit a revised protocol to CDSCO.
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