Lupin Gets CDSCO Panel Nod to Study FDC of Fluticasone, Glycopyrronium, Vilanterol Inhalation Powder

This came after the drug major Lupin presented the Phase IV clinical trial protocol before the committee.

Phase IV trials are conducted as postmarketing efforts to further evaluate the characteristics of the new drug with regard to safety, efficacy, new indications for additional patient populations, and new formulations.

Fluticasone Furoate is used in the treatment of sneezing and runny nose due to allergies. Fluticasone Furoate is a steroid that works by blocking the production of certain chemical messengers in the body that cause inflammation (redness and swelling) and allergies.

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.

Vilanterol is in a class of medications called long-acting beta-agonists (LABAs). These medications work by relaxing and opening air passages in the lungs, making it easier to breathe.

At the recent SEC meeting for Pulmonary held on 4th Jan 2023, the expert panel reviewed the Phase IV clinical trial protocol of the FDC Fluticasone Furoate plus Glycopyrronium Bromide plus Vilanterol Trifenatate Inhalation Powder in capsule presented by the drug major Lupin.

After detailed deliberation, the committee recommended granting permission to conduct the Phase IV clinical trial.

Furthermore, the expert panel suggested that the firm should submit the Phase IV clinical trial report to CDSCO for further review by the committee.

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