Include more Govt sites: CDSCO Panel Tells Glenmark on Asthma Drug Combination
New Delhi: Citing that more government sites shall be included in the study with geographical distribution, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Glenmark Pharmaceutical to revise Phase III clinical trial protocol of Glycopyrrolate plus Fluticasone Furoate plus Vilanterol Trifenatate Powder for inhalation in capsule, indicated for the treatment of uncontrolled asthma.
This came after the drug major Glenmark Pharmaceutical presented their proposal along with justification for the safety of the 200 mcg dose of Fluticasone Furoate in a three-drug combination in uncontrolled asthma along with Phase III clinical trial (CT) Protocol before the committee.
Glycopyrrolate, also known as glycopyrronium, is an anticholinergic drug. It is a synthetically created quaternary amine with pyridine and a cyclopentane moiety within the compound's structure. Glycopyrrolate has been widely used as a preoperative medication to inhibit salivary gland and respiratory secretions.
Glycopyrrolate inhibits the action of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine.
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.
Fluticasone works to inhibit inflammatory cells, such as mast cells, neutrophils, lymphocytes, and macrophages. Plus, fluticasone helps to inhibit the secretion of histamines, cytokines, and leukotrienes which are commonly released with asthma and allergic responses.
Vilanterol stimulates beta-2 receptors in the lungs. Beta-2 receptors mediate bronchodilation, so stimulation of these receptors leads to bronchodilation.
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).
At the recent SEC meeting Pulmonary Drugs, held on 21 September 2023, the expert panel reviewed the proposal presented by the drug major Glenmark Pharmaceutical along with a justification for the safety of the 200 mcg dose of Fluticasone Furoate in three-drug combinations in uncontrolled asthma along with Phase III CT Protocol of Glycopyrrolate plus Fluticasone Furoate plus Vilanterol Trifenatate Powder for inhalation in the capsule.
After detailed deliberation, the committee considered the safety of the 200 mcg dose of Fluticasone Furoate in combination and recommended that:
1. The study arm for glycopyrronium 50 mcg + Fluticasone Furoate 200 mcg + Vilanterol 25 mcg should be separate in the Phase III CT Protocol.2. The study arm for Glycopyrronium 50 mcg + Fluticasone Furoate100 mcg + Vilanterol 25 mcg should also be separated with proper justification in the Phase III CT Protocol.3. More Govt. sites shall be included in the study with geographical distribution in Phase III CT Protocol.
Accordingly, the expert panel suggested that the firm should submit a revised Phase III CT Protocol to CDSCO for further review by the committee.
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