Glenmark Pharmaceuticals Receives FDA Clearance of IND for GSP 304

Glenmark Pharmaceuticals, a global pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) application to begin a Phase 2 study of GSP 304 (tiotropium bromide) for administration by nebulization for the long term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD).

Glenmark plans to initiate clinical development with a Phase 2 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.

“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 D.O., President and Chief Medical Officer at Glenmark Pharmaceuticals Inc. “Moving GSP 304 into Phase 2 is a great example of that focus and, if approved, will be the first nebulized form of tiotropium bromide. This milestone further affirms our goal of providing new treatment options that meet significant unmet medical needs.”