Submit CT Protocol, Toxicity Report: CDSCO panel Tells Glenmark on respiratory drug combination
New Delhi: Directing to conduct Phase III clinical trail and inhalation toxicity study of respiratory fixed dose combination drug Glycopyrronium Bromide (50mcg /50mcg) plus Fluticasone Furoate (100mcg/ 200mcg) plus Vilanterol Trifenatate (25mcg/25mcg) Dry Powder for inhalation, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has recommended the drug maker Glenmark Pharmaceuticals to submit protocol for clinical trial and toxicity report for review by the committee.
Glycopyrronium is a racemic mixture of two enantiomers. They are both quaternary ammonium compounds and long acting muscarinic antagonists. It is one of the most commonly prescribed anticholinergic medications.
Early research into glycopyrronium use was for its indication as an adjunct therapy in the treatment of peptic ulcers. Later research, taking advantage of the systemic distribution of muscarinic receptors through the body, found that glycopyrronium could also be used for reducing sweat gland, oral, airway, and gastric secretions; as well as reducing cardiac inhibitory reflexes; and reducing bronchoconstriction in COPD.
Fluticasone furoate is a synthetic glucocorticoid available as an inhaler and nasal spray for various inflammatory indications. It can be used as maintenance treatment of asthma and/or chronic obstructive pulmonary disease (COPD) depending on the product.
Vilanterol is a selective long-acting beta2-adrenergic agonist (LABA) with inherent 24-hour activity for once daily treatment of COPD and asthma. 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). Increases in cyclic AMP are associated with relaxation of bronchial smooth muscle and inhibition of release of hypersensitivity mediators from mast cells in the lungs.
At the recent SEC meeting for Pulmonary held on September 29,2022, the expert panel reviewed the proposal along with justification for CT and BE study waiver presented by drug major Glenmark for fixed dose combination drug (FDC) Glycopyrronium Bromide plus Fluticasone Furoate plus Vilanterol Trifenatate Dry Powder for inhalation.
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