Sun Pharma Told to Limit Phase III Revefenacin Study to Triple Therapy COPD Patients
New Delhi: Recommending to revise the inclusion criteria so that subjects on triple therapy only shall be included in the study, the Subject Expert Committee (SEC), functional under the Central Drugs Standard Control Organization (CDSCO), has opined Sun Pharmaceutical Industries should revise its Phase III clinical trial protocol for Revefenacin Inhalation Solution (175 mcg/3 ml).
This came after the drug major Sun Pharmaceutical Industries presented the proposal for a grant of permission to manufacture and market Revefenacin Inhalation solution 175mcg/3ml along with phase III Clinical Trial protocol (Protocol No. ICR/25/004, Version No. 2.0 dated 03.07.2025) and bioequivalence (BE) waiver before the committee.
The firm presented the Phase III clinical trial (CT) protocol, including study objectives, study endpoints, study design, inclusion criteria, exclusion criteria, clinical investigations, schedule of assessments and proposed study sites before the committee.
Revefenacin is a novel biphenyl carbamate tertiary amine agent that belongs to the family of the long-acting muscarinic antagonists (LAMA). The labile primary amide in the structure produces a "soft-drug" site that allows rapid systemic clearance and minimizes the systemically mediated adverse reactions.
Revefenacin is an inhaled bronchodilator muscarinic antagonist with a long-acting bronchodilation activity. It has been shown to present a high affinity and behave as a competitive antagonist of the five muscarinic cholinergic receptors.
Studies have indicated that revefenacin dissociates significantly slower from the muscarinic receptor M3 when compared to the receptor M2, 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. Lastly, due to the duration of the bronchodilation, revefenacin is considered a long-acting muscarinic antagonist, which allows it to be dosed once daily.
Revefenacin is indicated as an inhalation solution for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
At the recent SEC meeting for pulmonary drugs, the expert panel reviewed the proposal presented by Sun Pharmaceutical Industries for a grant of permission to manufacture and market Revefenacin Inhalation solution 175mcg/3ml along with phase III Clinical Trial protocol (Protocol No. ICR/25/004, Version No. 2.0 dated 03.07.2025) and bioequivalence (BE) waiver.
After detailed deliberation, the committee recommended that the firm should revise the inclusion criteria so that subjects on triple therapy only shall be included in the study as per the protocol presented by the firm and the revised protocol shall be submitted to CDSCO.
