A review of the clinical efficacy and safety of MP-AzeFlu, a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate, in clinical studies conducted during different allergy seasons in the US

Abstract

A novel intranasal formulation of azelastine HCl (AZE, an antihistamine) and fluticasone propionate (FP, a corticosteroid) in a single spray (MP-AzeFlu [Dymista®]) was studied in four randomized, double-blind, placebo-controlled trials of patients with seasonal allergic rhinitis conducted in the US. Study sites were distributed so that all major US geographic regions and the prevalent pollens within these regions were represented. Spring and summer studies included patients aged 12 years and older with allergy to grass and tree pollens. Fall studies enrolled patients with allergy to weeds, in particular ragweed. In addition, a study was conducted during the winter months in patients with allergy to mountain cedar pollen in TX, USA. Regardless of allergy season or prevalent pollen, MP-AzeFlu improved nasal symptoms of allergic rhinitis (AR) to a significantly greater degree than AZE or FP, two treatments that currently are recommended as the first-line AR therapy. MP-AzeFlu improved all individual AR symptoms and was significantly better than FP and AZE for nasal congestion relief, which is generally accepted as the most bothersome symptom for AR patients. The onset of action was within 30 minutes. MP-AzeFlu also provided clinically important improvement in the overall Rhinoconjunctivitis Quality of Life Questionnaire score and significantly improved ocular symptoms of rhinitis compared to placebo. Favorable characteristics of the MP-AzeFlu formulation as well as superior clinical efficacy make it an ideal intranasal therapy for AR.

Keywords: Dymista; Texas mountain cedar; grass pollen; intranasal therapy; ragweed; seasonal allergic rhinitis.

Figure 1

A summary of primary efficacy results in the MP-AzeFlu clinical studies in patients with moderate-to-severe SAR (values shown are placebo subtracted). Notes: (A) MP 4001; *P≤0.003 vs generic fluticasone, Astelin. (B) MP 4002; *P≤0.034 vs fluticasone, azelastine. (C) MP 4004; *P≤0.038 vs fluticasone, azelastine. (D) MP 4006; *P≤0.029 vs fluticasone, azelastine. ^aAdapted from Meltzer E, Ratner P, Bachert C, et al. Clinically relevant effect of a new intranasal therapy (MP29-02) in allergic rhinitis assessed by responder analysis. Int Arch Allergy Immunol. 2013;161(4):369–377. Copyright © 2013 Karger Publishers, Basel, Switzerland.^{13 b}Adapted from J Allergy Clin Immunol; 129(5). Carr W, Bernstein J, Lieberman P, et al. A novel intranasal therapy of azelastine with fluticasone for the treatment of allergic rhinitis. 1282–1289. Copyright 2012, with permission from Elsevier.^{10 c}Numerical difference in TNSS from fluticasone. MP-AzeFlu is composed of 137 µg AZE and 50 µg FP per spray. Studies: MP 4001, Texas mountain cedar, Winter; MP 4002, Spring; MP 4004, Fall; and MP 4006, Spring to Fall. Abbreviations: SAR, seasonal allergic rhinitis; LS, least-squares; FP, fluticasone propionate; AZE, azelastine HCl; TNSS, total nasal symptom score.

Figure 2

Time-to-response curves showing the percentage of patients with a 50% improvement in rTNSS (A) or with a score of ≤1 point for each nasal symptom (B) after 2 weeks of treatment in studies MP 4002, MP 4004, and MP 4006. Notes: Adapted from J Allergy Clin Immunol; 129(5). Carr W, Bernstein J, Lieberman P, et al. A novel intranasal therapy of azelastine with fluticasone for the treatment of allergic rhinitis. 1282–1289. Copyright 2012, with permission from Elsevier. MP-AzeFlu is composed of 137 µg AZE and 50 µg FP per spray. Abbreviations: rTNSS, reflective total nasal symptom score; FP, fluticasone propionate; AZE, azelastine HCl; PLA, placebo.

Figure 3

Time-to-response curves showing the percentage of patients with a 50% improvement in rTNSS (A) or with a score of ≤1 point for each nasal symptom (B) after 2 weeks of treatment in study MP 4001. Notes: Adapted from Meltzer E, Ratner P, Bachert C, et al. Clinically relevant effect of a new intranasal therapy (MP29-02) in allergic rhinitis assessed by responder analysis. Int Arch Allergy Immunol. 2013;161(4):369–377. Copyright © 2013 Karger Publishers, Basel, Switzerland. MP-AzeFlu is composed of 137 µg AZE and 50 µg FP per spray. Abbreviations: rTNSS, reflective total nasal symptom score; FP, fluticasone propionate; AZE, azelastine HCl; PLA, placebo.