New Delhi: After deliberating the Phase III clinical trial protocol of the pulmonary drug Almitrine and Ifenprodil, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the Central Drug Research Institute- Council of Scientific & Industrial Research (CDRI-CSIR) to submit preclinical data, proof of the concept for the proposed drugs, the rationale for inclusion/exclusion criteria and the rationale for the proposed study.
This came after the Central Drug Research Institute- Council of Scientific & Industrial Research (CDRI-CSIR) presented the Phase-III clinical trial protocol before the committee.
Almitrine is an agonist at the peripheral chemoreceptors expressed on carotid bodies. It enhances respiration in patients with the chronic obstructive pulmonary disease by increasing the arterial oxygen tension while decreasing the arterial carbon dioxide tension.
Ifenprodil and related compounds are a class of highly specific noncompetitive antagonists of NMDARs containing GluN2B subunits. Ifenprodil has an unusual form of activity dependence and its mechanism of action may involve an increase in proton inhibition of NMDA receptors.
At the recent SEC meeting for Pulmonary held on March 21st 2023, the expert panel reviewed the Phase III clinical trial protocol of the Almitrine and Ifenprodil 50mg & 20mg Tablets.
After detailed deliberation, the committee noted that the applicant has not provided adequate preclinical data/proof of the concept for the proposed drugs, the rationale for inclusion/exclusion criteria and the rationale for the proposed study.
The committee recommended that the applicant should submit the above data to CDSCO for further review by the committee.