USFDA clears Glenmark's investigational new drug application

Drug major Glenmark today said the US health regulator has cleared its investigational new drug (IND) application to begin a phase two study of GSP 304 to be used for treatment of a respiratory disease.
"The US Food and Drug Administration (FDA) cleared the company's investigational new drug (IND) application to begin a phase two study of GSP 304 (tiotropium bromide) for administration by nebulisation for the long term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD)," Glenmark said in a BSE filing.
Glenmark said it plans to initiate clinical development with a phase two study of GSP 304, a new orally administered formulation, in subjects with mild to moderate COPD, as determined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.

"The efficacy, pharmacokinetics, and safety profiles of currently available formulations of tiotropium bromide are well established," it added.
"Respiratory is a core area of focus for Glenmark as we continue to harness our heritage in generics and evolve into a specialty, innovation-focused company," said Fred Grossman DO, President and Chief Medical Officer at Glenmark Pharmaceuticals.
"Moving GSP 304 into phase two is a great example of that focus and, if approved, will be the first nebulised form of tiotropium bromide. This milestone further affirms our goal of providing new treatment options that meet significant unmet medical needs."
The stock was trading 0.10 per cent higher at Rs 905.50 on BSE.