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news.CyDex Pharmaceuticals, a specialty pharmaceutical company, has successfully completed an early proof-of-concept Phase II clinical trial of its Captisol-Enabled budesonide/azelastine nasal spray for seasonal allergic rhinitis.
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CyDex has an international patent cooperation treaty application pending for this combination nasal spray product.
A randomized, double-blind, placebo-controlled, three-way cross-over study was conducted in 108 seasonal allergic rhinitis patients to compare the relative efficacy of Captisol-Enabled budesonide/azelastine nasal spray (single solution) and rhinocort aqua (suspension) + astelin nasal spray (solution) against placebo nasal spray solution in the treatment of allergic rhinitis in an environmental exposure chamber.
Theron Odlaug, president and CEO of CyDex, said: “Our ongoing R&D at CyDex, as demonstrated by this Phase II clinical trial, will continue to propel the company forward as we grow to become a formidable specialty pharmaceutical company.
“The Captisol Enabled budesonide azelastine nasal spray product is one we intend to license to a commercial partner. Our ongoing strategy involves development of products to license as well as products we intend to retain, develop, and commercialize within CyDex Pharmaceuticals.”