Zydus Healthcare Gets CDSCO Panel Nod to study Fluticasone, Glycopyrronium, Vilanterol FDC metered dose inhalation
New Delhi: The drug major Zydus Healthcare has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the Phase III clinical trial of the fixed-dose combination containing Fluticasone Furoate, plus Glycopyrronium Bromide plus Vilanterol Trifenatate metered dose inhalation.
This came after Zydus Healthcare presented the proposal along with the Phase III clinical trial protocol and requested a bioequivalence study waiver before the committee.
Fluticasone is in a class of medications called corticosteroids. It works by blocking the release of certain natural substances that cause allergy symptoms. Fluticasone Furoate is a steroid that acts by blocking the production of certain chemical messengers in the body that cause inflammation (redness and swelling) and allergies.
Fluticasone is used to treat seasonal and year-round allergy symptoms such as stuffy/runny nose, itching, and sneezing. It may also reduce other symptoms of seasonal allergies such as red, itchy, and watery eyes.
Glycopyrronium bromide is a medication of the muscarinic anticholinergic group. It does not cross the blood–brain barrier and consequently has few to no central effects. It is given by mouth, via intravenous injection, on the skin, and via inhalation. It is a synthetic quaternary ammonium compound.
Glycopyrrolate, or glycopyrronium bromide inhibits parasympathetic nerve impulses by selectively blocking the binding of acetylcholine to muscarinic receptors.
Vilanterol trifenatate, a novel inhaled long-acting beta2 adrenoceptor agonist, is well tolerated in healthy subjects and demonstrates prolonged bronchodilation in subjects with asthma and chronic obstructive pulmonary disease (COPD).
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).
At the recent SEC meeting for pulmonary held on 5th September 2023, the expert panel reviewed the proposal presented by drug major Zydus Healthcare along with Phase III clinical trial protocol of pulmonary fixed-dose combination containing Fluticasone Furoate, plus Glycopyrronium Bromide plus Vilanterol Trifenatate metered dose inhalation.
After detailed deliberation, the committee recommended the grant of permission for conducting the proposed Phase III clinical trial.
In accordance with the above, the expert panel suggested that the firm should submit a Phase III clinical trial report for further review by the committee.
