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.
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery.
At the recent SEC meeting for pulmonary drugs held on 4th December 2024, the expert panel reviewed the justification for Phase III CT waiver before the committee.
After detailed deliberation, the committee reiterated its earlier recommendation dated 04.07.2024 and recommended that the firm should conduct Phase III clinical trial study with the proposed FDC.
Accordingly, the expert panel suggested that the firm should submit the phase III clinical trial protocol to CDSCO for further review by the committee.
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