Conduct Phase III CT: CDSCO Panel Tells Zydus Healthcare on FDC Dextromethorphan, Phenylephrine Syrup
New Delhi: Reviewing the justification for the Phase III clinical trial of Zydus Healthcare's fixed dose combination (FDC) pulmonary drug Dextromethorphan Hydrobromide plus Phenylephrine Hydrochloride Syrup, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the firm conduct the Phase III clinical trial of the proposed FDC.
In addition, the committee recommended the firm submit the Phase III clinical trial protocol of the proposed FDC for further review.
This came after Zydus Healthcare presented justification for the Phase III clinical trial waiver before the committee.
Dextromethorphan Hydrobromide is an antitussive (cough suppressants). It suppresses cough by reducing the activity of cough centre in the brain. Dextromethorphan is an Uncompetitive N-methyl-D-aspartate Receptor Antagonist and Sigma-1 Agonist. The mechanism of action of dextromethorphan is as an Uncompetitive NMDA Receptor Antagonist and Sigma-1 Receptor Agonist.
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