Mylan Gets CDSCO Panel Nod To Study COPD drug Revefenacin inhalation solution

This came after the firm presented the proposed Phase III clinical trial of Anticholinergic Revefenacin inhalation solution 175 mcg/3ml along with the revised Phase III Clinical Trail Protocol including the CT NOC (Clinical trial No Objection Certificate) conditions before the committee.

Revefenacin is an inhaled bronchodilator muscarinic antagonist with a long-acting bronchodilation activity. It has been shown to present a high affinity and behaved as a competitive antagonist of the five muscarinic cholinergic receptors.

Studies have indicated that revefenacin dissociates significantly slower from the muscarinic receptor M3 (hM3) when compared to the receptor M2 (hM2) which indicates a kinetic selectivity for this subtype. This competitive antagonism produces a suppressive action of the acetylcholine-evoked calcium mobilization and contractile responses in the airway tissue.5 Lastly, due to the duration of the bronchodilation, revefenacin is considered a long-acting muscarinic antagonist which allows it to be dosed once daily.

This response is very important for the therapy of COPD as the main goal is the reduce the frequency and severity of exacerbations which are normally driven by the presence of elevated cholinergic bronchoconstrictor tone mediated by muscarinic receptors on parasympathetic ganglia and airway smooth muscle.6 Hence, the activity of revefenacin produces a potent and long-lasting protection against the bronchoconstrictor response to acetylcholine or methacholine.

At earlier SEC meeting for Pulmonary held on 25.02.2022, the expert panel recommended the firm to conduct the study subject to condition that the firm should monitor evidence for development of glaucoma and urinary retention during follow up visits.

In connection with the above, at the recent SEC meeting for Pulmonary held on 07.07 2022,the expert panel reviewed the the revised Phase-III Clinical Trial Protocol of the drug Revefenacin inhalation solution 175 mcg/3ml including the Clinical trial No Objection Certificate (CT NOC) conditions presented by the drug maker Mylan Pharmaceutical.

After detailed deliberation, the committee recommended the grant of permission to conduct Phase-III Clinical Trial Study as per revised Phase-III Clinical Trial Protocol (Protocol No. REVE-SGR-3001, Version 1.0, dated 03.03.2022).

Also Read:Drug-makers to add Hyponatraemia as adverse effect in package insert of Olanzapine: CDSCO Panel