Safety profile 52 weeks: Similar safety profile as standard therapy following 1 year of continuous use in patients with chronic rhinitis (i.e. perennial allergic rhinitis or non-allergic rhinitis). The most common treatment related adverse events were dysgeusia (2.5%) in the Dymista® group and headache (4.3%) in the fluticasone propionate group. None of these events were considered severe.
Safety profile 14 days: The proportion of seasonal allergic rhinitis patients treated with Dymista® who experienced a treatment related adverse event was very low, similar to standard therapies and placebo. The vast majority of these events were mild in nature.
UK/DYM/14/0070(1) Date of Prep: February 2017