According to Meda Pharmaceuticals, a Phase 3 trial has shown that its Dymista nasal spray, a combination formulation of azelastine hydrochloride and fluticasone propionate, produced a 40% greater improvement in nasal symptoms than fluticasone alone. Meda is presenting the results at the 2011 annual meeting of the American Academy of Asthma, Allergy and Immunology (AAAAI) and in an article in the online version of the Journal of Allergy Clinical Immunology.
The trial involved 800 patients with symptoms of seasonal allergic rhinitis. In addition to the improvement in the total nasal symptom score (TNSS), Dymista also demonstrated a reduction in onset of action, with symptom reduction occurring within 30 minutes of the first dose.
Meda CEO Anders Lönner says that the company now plans to submit an NDA for the product by mid-2011.
Read the company’s press release.