Lupin Gets CDSCO Panel Nod to Study Glycopyrronium Bromide, Vilanterol Trifenatate powder for inhalation in capsule

Glycopyrronium is an anticholinergic agent used to treat hyperhidrosis, severe drooling, and COPD, as well as in combination with other medications for ulcer treatment and anesthesia.

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 COPD.

During the recent SEC meeting for Pulmonary held on March 5th, 2024, the expert panel reviewed the Phase IV clinical trial protocol of the pulmonary FDC Glycopyrronium Bromide eq. to 50mcg Glycopyrronium 63mcg + Vilanterol Trifenatate eq. to 25mcg Vilanterol 40mcg powder for inhalation in capsule.

After detailed deliberation, the committee recommended the conduct of the Phase IV clinical trial. Furthermore, the expert panel suggested that the firm is required to submit the Phase IV clinical trial report to CDSCO for further review by the committee."

Also Read: CT waiver not considered, Conduct BA study: CDSCO Panel Tells Sun Pharma on Pulmonary FDC