CyDex Pharmaceuticals Presents Phase 2 Clinical Trial Results for Captisol-Enabled[R] Budesonide/Azelastine Combination Solution Nasal Spray at American Academy of Allergy Asthma and Immunology (AAAAI) Meeting.Reports Statistically Significant Results Company Seeks Commercial Partner LENEXA, Kan. -- CyDex Pharmaceuticals, Inc. today announced the presentation of Phase 2 clinical trial phase 2 clinical trial Phase 2 study. See Phase study. results of its novel, proprietary Captisol-Enabled([R]) budesonide/azelastine nasal spray (CDX-313) for seasonal allergic rhinitis seasonal allergic rhinitis, n See hay fever. seasonal allergic rhinitis Allergic rhinitis in which Sx wax and wane as a function of environmental pollen. See Allergic rhinitis. (SAR (Segmentation And Reassembly) The protocol that converts data to cells for transmission over an ATM network. It is the lower part of the ATM Adaption Layer (AAL), which is responsible for the entire operation. See AAL. SAR - segmentation and reassembly ). The budesonide/azelastine combination nasal spray demonstrated statistically significant improved results over a nasal spray placebo. A randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , 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([R])/ (Suspension) + Astelin([R]) 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 onset of action Pharmacology The length of time needed for a medicine to become effective. See Therapeutic drug monitoring. 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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 antihistamine (ăn'tĭhĭs`təmēn), any one of a group of compounds having various chemical structures and characterized by the ability to antagonize the effects of histamine. currently marketed as Astelin([R]) nasal spray. Captisol([R]), CyDex's patented sulfobutyl ether -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 phase 3 clinical trial Phase 3 study. See Phase study. with a development and commercialization partner. About CyDex Pharmaceuticals CyDex Pharmaceuticals, Inc. is a specialty pharmaceutical company developing products and licensing its Captisol([R]) 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. drug master file Drug Master File or DMF is a document prepared by a manufacturer in the pharmaceutical industry and submitted solely at his discretion to the Food and Drug Administration (FDA). There is no requirement by law or FDA regulation to present a DMF. 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 privately held company A firm whose shares are held within a relatively small circle of owners and are not traded publicly. located in suburban Kansas City. To learn more about the company, please visit www.cydexpharma.com. Rhinocort Aqua is a registered trademark of AstraZeneca. Astelin is a registered trademark of Meda Pharmaceuticals. |
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