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Glenmark gets go-ahead from US FDA to start phase II clinical trials for respiratory drug.

M2 EQUITYBITES-March 8, 2017-Glenmark gets go-ahead from US FDA to start phase II clinical trials for respiratory drug

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Glenmark Pharmaceuticals Ltd (NSE: GLENMARK) has been granted approval by the US Food and Drug Administration (FDA) to begin phase II clinical trials for its respiratory drug GSP 304 (tiotropium bromide), the company announced on Wednesday.

The approved trials will allow for the administration of the respiratory drug using a nebuliser in patients with chronic obstructive pulmonary disease (COPD).

The Mumbai-based pharma firm said that the effectiveness, pharmacokinetics and safety profiles of the available formulations of tiotropium bromide had been well established. The compound is currently available in spray and powder form and is marketed by Boehringer Ingelheim in the US under the brand names of Spiriva and Spiriva Respimat.

Glenmark has plans to start a randomised, placebo-controlled, double-blind, dose-ranging phase II trial in a bid to study GSP 304 with an active open-label comparator (Spiriva Respimat).

The firm explained: "Approximately 155 subjects will be randomised and treated for three weeks in order to inform the dose selection for phase III using pharmacokinetic and pharmacodynamic parameters."

Fred Grossman, president and chief medical officer at Glenmark, 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. Moving GSP 304 into phase II is a great example of that focus and, if approved, it will be the first nebulised form of tiotropium bromide."

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Publication:M2 EquityBites (EQB)
Date:Mar 8, 2017
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