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

New Delhi: Reviewing the Phase IV clinical trial protocol of Lupin's pulmonary FDC (Fixed Dose Combination) Glycopyrronium Bromide plus Vilanterol Trifenatate powder for inhalation in capsule, the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organization (CDSCO) has approved the firm conduct the Phase IV clinical trial of the said combination.

This decision came after the firm presented the Phase IV clinical trial protocol before the committee.

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."

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