Download CyDex Pharmaceuticals Presents Phase 2 Clinical Trial Results for

CyDex Pharmaceuticals Presents Phase 2 Clinical Trial Results
for Captisol-Enabled® Budesonide/Azelastine Combination Solution
Nasal Spray at American Academy of Allergy Asthma and
Immunology (AAAAI) Meeting
Reports Statistically Significant Results
Company Seeks Commercial Partner
March 16, 2009 08:30 AM Eastern Daylight Time
2009 AAAAI Annual Meeting
LENEXA, Kan.--(BUSINESS WIRE)--CyDex Pharmaceuticals, Inc. today announced the
presentation of Phase 2 clinical trial results of its novel, proprietaryCaptisolEnabled® 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 CaptisolEnabled 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-Enabledbudesonide/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-Enabledbudesonide/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 [email protected] or 913.685.8850. CyDex is a privately held company
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.
Contacts
CyDex Pharmaceuticals, Inc.
Allen K. Roberson, 913-685-8850
Chief Financial Officer
[email protected]