Zydus Healthcare gets CDSCO Panel nod to study Fluticasone Furoate, Glycopyrronium, Vilanterol FDC
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved drug major Zydus Healthcare's proposal to conduct the Phase III clinical trial of the pulmonary drug combination Fluticasone Furoate plus Glycopyrronium plus Vilanterol Trifenatate powder for inhalation in a capsule.
This came after the firm presented the proposal and Phase III clinical trial protocol before the committee.
The combination of fluticasone and vilanterol is used to control wheezing, shortness of breath, coughing, and chest tightness caused by asthma and chronic obstructive pulmonary (COPD; a group of diseases that affect the lungs and airways, which includes chronic bronchitis and emphysema) in adults.
Fluticasone nasal spray is used to treat sneezing, itchy or runny nose, or other symptoms caused by hay fever. It is also used to treat chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. This medicine belongs to the family of medicines known as corticosteroids (cortisone-like medicines).
Glycopyrronium is an anticholinergic agent used to treat hyperhidrosis, severe drooling, and COPD, used with other medications to treat ulcers, and used in anesthesia.
Vilanterol is a selective long-acting beta2-adrenergic agonist. Its pharmacological effect is attributable to stimulation of intracellular adenylyl cyclase which catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cAMP). Increases in cyclic AMP are associated with the relaxation of bronchial smooth muscle and inhibition of the release of hypersensitivity mediators from mast cells in the lungs.
At the recent SEC meeting for pulmonary held on 5th October 2023, the expert panel reviewed the proposal along with the Phase III clinical trial protocol of the FDC pulmonary drug Fluticasone Furoate plus Glycopyrronium plus Vilanterol Trifenatate powder for inhalation in capsule presented by the drug major Zydus Healthcare.
After detailed deliberation, the committee recommended the grant of permission for conducting the proposed Phase III clinical trial.
In addition, the expert panel suggested that the firm should submit a Phase III clinical trial report to CDSCO for further review by the committee.
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