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Dymista safe, effective in children with seasonal allergic rhinitis

WASHINGTON — Results from two trials showed that Dymista, a single formulation nasal spray of azelastine and fluticasone propionate, was effective at treating allergic rhinitis and generally well-tolerated in children aged younger than 12 years, according to data presented at the 2015 AAP National Conference and Exhibition.

“[Our study] was an open label study in children 4 to 12 years of age,” Todd A. Mahr, MD, of Gundersen Lutheran Medical Center in La Crosse, Wisconsin, told Infectious Diseases in Children. “What we were able to show was that adverse effects from the Dymista was no different than with fluticasone alone. The Dymista was also effective and well-tolerated when given as just one spray in each nostril twice daily.”

Mahr and colleagues conducted two studies, the first tested the safety of Dymista (MP-AzeFlu, Meda Pharmaceuticals) in a cohort of 405 children aged 4 to 12 years. Three hundred four patients were administered Dymista, and 101 children were assigned fluticasone propionate during a 3-month safety trial. Adverse events were confirmed via parent reporting, nasal examinations, vital signs and laboratory assessments. In the double blind second study, 173 children aged younger than 12 were administered MP-AzeFlu, and a second group (n = 175) received a placebo for 2 weeks to determine efficacy.

Study results showed that the number of adverse events reported in the MP-AzeFlu group were similar to those reported in the fluticasone propionate group. Epistaxis was the most commonly reported adverse event, affecting 10% of the MP-AzeFlu group vs. 9% of the fluticasone propionate group. The only adverse event reported less frequently in the MP-AzeFlu group was diarrhea (1% vs. 4%).

The 2-week efficacy results showed a notable change in baseline 12-hour reflective total nasal symptom score (P = .02), which favored MP-AzeFlu over the placebo.

“These studies were the basis for the Dymista pediatric indication for patients 6 to 11 years of age with seasonal allergic rhinitis,” Mahr said. “Again, for providers, this now gives us a prescription option to help these children who have failed other over-the-counter therapy.” – by David Costill

Reference:
Mahr TA, et al. Abstract 30703. Presented at: AAP National Conference and Exhibition; Oct. 24-27, 2015; Washington, D.C.

Disclosure: The researchers report no relevant financial disclosures.