CyDex Pharmaceuticals Presents Phase 2 Clinical Trial Results For Captisol-Enabled Budesonide/Azelastine Combination Solution Nasal Spray

Main Category: Allergy
Also Included In: Ear, Nose and Throat;  Clinical Trials / Drug Trials
Article Date: 18 Mar 2009 - 1:00 PDT

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CyDex Pharmaceuticals, Inc. announced the presentation of Phase 2 clinical trial results of its novel, proprietary Captisol-Enabled® budesonide/azelastine nasal spray (CDX-313) for seasonal allergic rhinitis (SAR). The budesonide/azelastine combination nasal spray demonstrated statistically significant improved results over a nasal spray placebo.

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 a placebo nasal spray solution in the treatment of allergic rhinitis in an environmental exposure chamber.

Relief of all nasal symptoms as measured by the Total Nasal Symptom Score (TNSS) was significantly greater than placebo from 20 minutes following administration until the session end (10 hours) for both Captisol-Enabled budesonide/azelastine and Rhinocort Aqua/Astelin (p<0.0001). Onset of action of relief from itchy nose and sneezing were significantly faster at 10 minutes for Captisol-Enabled budesonide/azelastine compared to Rhinocort Aqua/Astelin.

Relief of all eye symptoms as measured by the Total Ocular Symptom Score (TOSS) was significantly greater than placebo from 40 minutes following administration until the session end (10 hours) for both Captisol-Enabled budesonide/azelastine and Rhinocort Aqua/Astelin (p<0.0001). Captisol-Enabled budesonide/azelastine provided the same or greater numerical TOSS relief than Rhinocort Aqua/Astelin and longer-lasting relief of red/burning eyes and itchy eyes.

Theron Odlaug, Ph.D., President and CEO of CyDex, commented, "Our ongoing research and development progress at CyDex, as demonstrated by this Phase 2 clinical trial, will continue to propel us 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 Captisol-Enabled Budesonide/Azelastine Nasal Spray

Captisol-Enabled Budesonide/Azelastine Nasal Spray is being studied as a novel combination of two drugs used to treat seasonal allergic rhinitis: budesonide and azelastine. Budesonide has been used clinically for more than 20 years. Azelastine is an antihistamine currently marketed as Astelin® nasal spray. Captisol®, CyDex's patented sulfobutyl ether β-cyclodextrin, enables the combination of the two drugs in an aqueous solution. CyDex has previously shown that Captisol-Enabled Budesonide provided more non-nasal symptom relief than the currently marketed product. The safety data generated to date has shown Captisol-Enabled Budesonide/Azelastine Nasal Spray to be well tolerated with no significant adverse events. CyDex is planning a Phase 3 clinical trial with a development and commercialization partner.

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. To learn more about the company, please visit http://www.cydexpharma.com.

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CyDex Pharmaceuticals