Phase 3 Results for Dymista for Allergic Rhinitis
Meda announced new results from its Phase 3 study of Dymista (azelastine HCl and fluticasone propionate; Meda) nasal spray for the treatment of allergic rhinitis. Data from three randomized, placebo-controlled, parallel-group studies including over 2,200 patients show that Dymista is more effective than intranasal fluticasone propionate or azelastine nasal sprays in reducing nasal rhinitis symptoms, and provides clinically relevant symptom improvement significantly earlier in more patients when compared to current standard therapies.
In study MP4001, 49.1% of patients treated with Dymista achieved a clinically significant 50% improvement in rTNSS (Total Nasal Symptom Score). Patients treated with Dymista reached this clinically relevant response 5–6 days earlier than patients treated with fluticasone propionate or azelastine monotherapy. Onset of action was achieved within 30 minutes following Dymista administration. Dymista also significantly reduced ocular rTOSS (Total Ocular Symptom Score) symptoms to a greater extent than fluticasone propionate. The NDA application for Dymista was recently accepted by the FDA and will go under review.
Dymista is a combination azelastine HCL and fluticasone propionate nasal spray formulation for the treatment of seasonal allergic rhinitis in patients 12 years and older.
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