CyDex reports encouraging results from Phase II allergic rhinitis trial

A randomized, double-blind, placebo-controlled, three-way cross-over study was conducted in 108 seasonal allergic rhinitis (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.

According to CyDex, relief of all nasal symptoms as measured by the total nasal symptom score 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, the company said. Theron Odlaug, president and CEO of CyDex, said: "Our ongoing R&D progress at CyDex, as demonstrated by this Phase II 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."