CyDex Pharmaceuticals Announces Successful Completion Of Phase II Clinical Trial For Budesonide/Azelastine Combination Solution Nasal Spray

Main Category: Ear, Nose and Throat
Also Included In: Allergy
Article Date: 05 Feb 2009 - 6:00 PDT

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CyDex Pharmaceuticals, Inc. announced that it has successfully completed an early proof-of-concept phase II clinical trial of its Captisol-Enabled® budesonide/azelastine nasal spray for seasonal allergic rhinitis (SAR). CyDex has an international PCT patent application pending for this combination nasal spray product.

A Randomized, Double-Blind, Placebo-Controlled, Three-Way Cross-Over Study was conducted in 108 SAR 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 (EEC).

"CyDex's CAPTISOL®, a chemically modified sulfobutylether beta-cyclodextrin, potentially may increase the efficacy of medications such as nasal steroid sprays by potentiating delivery," said B.J. Ferguson, M.D. associate professor, Department of Otolaryngology, University of Pittsburgh School of Medicine, following the AAOA Advisory Board review of the preliminary results. "If comparative clinical trials show significant clinical efficacy, then we should anticipate a strong and significant new entrant in the allergic rhinitis market. The completion of this trial is a very promising development."

Theron Odlaug, Ph.D., President and CEO of CyDex, commented, "Our ongoing research and development 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."

About CyDex Pharmaceuticals

CyDex Pharmaceuticals, Inc. is a specialty pharmaceutical company developing products and licensing its CAPTISOL® technology. CyDex is developing its own pipeline of products using its enabling technology solutions, and partnering with leading pharmaceutical, specialty pharmaceutical and biotechnology companies. The company maintains patents in the U.S. and worldwide for its CAPTISOL and cyclodextrin technologies, and a comprehensive FDA drug master file for client use. For additional information on business development opportunities, please contact Ralph Johnston at rjohnston@cydexpharma.com or 913.685.8850. CyDex is a privately held company located in suburban Kansas City.

CyDex Pharmaceuticals

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