Efficacy of MP-Azeflu in the Treatment of Postnasal Drip and Rhinorrhea in Patients with Seasonal Allergic Rhinitis (SAR)

Rationale: The objective of this analysis was to evaluate MP-AzeFlu (Dymista), an intranasal formulation of azelastine HCL (AZE) and fluticasone propionate (FP) in a single delivery device, for the treatment of postnasal drip (PND) and rhinorrhea in patients with SAR.

Methods: A total of 3389 patients with PND severity assessments and 3392 with rhinorrhea assessments were analyzed from three 2-week, double-blind, placebo- and active-controlled studies comparing MP-AzeFlu to FP and AZE monotherapy.  Treatments were administered 1 spray per nostril bid (AM and PM); total daily doses of FP and AZE were 200 mcg and 548 mcg, respectively.  The primary efficacy variable was change from baseline in the 12-hour reflective total nasal symptom score (rTNSS), which included nasal congestion, sneezing, itchy nose, and rhinorrhea scored twice daily (AM and PM) on a 4-point (0-3).  Change from baseline in PND was evaluated in a similar pre-specified analysis.

Results: MP-AzeFlu was statistically superior (P<.05) to FP, AZE, and placebo for improving overall rTNSS in all studies.  MP-AzeFlu was also statistically superior to FP (P<.05) and AZE (P≤.001) for improving PND and rhinorrhea in a meta-analysis of the three studies.  Statistical or numerical improvements favoring MP-AzeFlu vs. FP and AZE were seen on each day of the 14-day study periods for each nasal symptom.

Conclusions: Results of these analyses demonstrated that MP-AzeFlu significantly improved the overall complex of nasal symptoms of SAR, including PND, compared to monotherapy with either FP or AZE.