Glenmark Pharmaceuticals said today that the FDA approved its Investigational New Drug application for a Phase II study of its nebulized tiotropium bromide.
The Mahwah, N.J.-based company plans to enroll 155 patients with mild to moderate chronic obstructive pulmonary disease and evaluate its GSP 304 formulation as a daily maintenance treatment for bronchospasm.
“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,” president & chief medical officer Fred Grossman said in prepared remarks. “Moving GSP 304 into Phase II 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.”
Development of the etonogestrel/ethinyl estradiol contraceptive is under way, according to the companies, and they plan to file an Abbreviated New Drug Application in fiscal 2019.
San Antonio-based Evestra said it will develop the product exclusively for Glenmark within the U.S. market and is slated to receive milestone payments contingent upon the vaginal ring’s development. Evestra is also eligible to receive royalties on net sales.