Phase 2 study of budesonide/azelastine nasal spray for seasonal allergic rhinitis

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

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