Dr Reddys, Zuventus get CDSCO panel okay to conduct Covid-19 trials on Aviptadil
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted permission to Dr Reddy's Laboratories (DRL) and Zuventus Healthcare to conduct clinical trials on Aviptadil injectable formulation for Covid-19.
The two drugmakers have got a go-ahead to conduct a Phase III Clinical Trial of repurposed medicines for Covid-19 on the condition that criteria for the discharge of patients from ICU should be defined clearly in their protocols.
Repurposed drugs are those that have a predominant medical use for a particular ailment. Owing to the multipurpose properties of the active ingredient of the drug, they are repurposed for other uses.
The formulation, Aviptadil, is an analog of the vasoactive intestinal polypeptide for the treatment of erectile dysfunction.
The green signal came after the SEC noted that Zuventus had presented revised Phase 3 clinical trial protocol before the committee, and after "detailed deliberation", it recommended a grant of permission of Phase 3 trials with the drug, "subject to the condition that criteria for discharge of patients from intensive care unit should be defined clearly in the protocol".
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