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Glenmark Pharmaceuticals, a global pharmaceutical company, has announced that the US 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 DO, president and chief medical officer at Glenmark Pharmaceuticals. “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.”
The phase 2, US-based study is a 5-arm, parallel group, randomized, placebo-controlled, double-blind, dose-ranging study with an active open-label comparator (SPIRIVA RESPIMAT). Approximately 155 subjects will be randomized and treated for 3 weeks in order to inform the dose selection for phase 3 using pharmacokinetic and pharmacodynamic parameters.
Glenmark gets us fda, begin phase 2 study, gsp, patients, copd
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