Cipla gets CDSCO Panel nod to study Revefenacin Inhalation solution
New Delhi: The pharmaceutical major Cipla has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) for conducting Phase III clinical trials of Revefenacin Inhalation Solution 175 mcg/3 ml.
This came after the drug major Cipla presented the proposal for grant of permission to manufacture and market Revefenacin Inhalation solution 175 mcg/3ml along with a bioequivalence (BE) study waiver and phase III clinical trial protocol 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 (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. 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 Cipla for grant of permission to manufacture and market Revefenacin Inhalation solution 175 mcg/3ml along with a bioequivalence (BE) study waiver and phase III clinical trial protocol.
After detailed deliberation, the committee recommended the grant of permission to conduct the Phase III clinical trial as per the protocol presented.
