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General questions about Dymista®

Dymista® is a novel intranasal formulation of fluticasone propionate and azelastine hydrochloride in an advanced delivery system. As with all topically administered medications, how it is constituted (i.e. formulation) and how it is delivered (i.e. device) are important determinants contributing to the final physiochemical properties of the drug, and ultimately to its efficacy, safety and ease of use. Within Dymista®, the active ingredients are constituted in a novel formulation (i.e. larger spray volume, different droplet size and lower viscosity) and improved device.

Dymista® is indicated for the relief of symptoms of moderate to severe seasonal and perennial allergic rhinitis if monotherapy with either intranasal antihistamine or glucocorticoid is not considered sufficient.

Dymista® should be administered one spray per nostril twice daily (morning and evening). Dymista Nasal Spray is suitable for long term use, the duration of treatment should correspond to the period of allergenic exposure. 

Each spray of Dymista® contains 50 µg of fluticasone propionate and137 µg of azelastine hydrochloride.

One 23 g suspension in 25 ml bottle of Dymista® delivers 120 sprays (i.e. 30 days of treatment plus priming doses)

Dymista® is suitable for long-term use. The duration of the treatment should correspond to the period of allergenic exposure.

Dymista® is indicated for the relief of symptoms of moderate to severe seasonal and perennial allergic rhinitis if monotherapy with either intranasal antihistamine or glucocorticoid is not considered sufficient.

Most patients attending their doctor have moderate to severe disease and continue to experience symptoms on treatment, even those using multiple therapies.

Questions about efficacy

Dymista® is twice as effective as 2 first line therapies, fluticasone propionate and azelastine nasal sprays, in providing relief from the entire rhinitis symptom complex, incorporating both nasal (congestion, itching, rhinorrhea and sneezing) and ocular symptoms (itching, redness and watering).  It is more effective regardless of symptom severity, even in those with more severe disease who are difficult to treat. More patients treated with Dymista® (1 in 2 patients) achieve substantial relief (i.e. 50% reduction in symptoms) and 1 in 6 achieve complete or near to complete symptom relief and many days faster than patients treated with fluticasone propionate or azelastine nasal sprays.

Questions about safety

Dymista® was very well tolerated following continuous use for 52 weeks in patients with chronic rhinitis (i.e. perennial allergic rhinitis or non-allergic (vasomotor) rhinitis). The most common treatment related adverse event was dysgeusia (2.5%) in the Dymista® group compared to headache (4.3%) in the fluticasone propionate group. None of these events were considered severe. There was also no appreciable reduction in fasting morning serum cortisol concentrations from baseline following 6 or 12 months continuous treatment with Dymista®.

Dymista® is very well tolerated in seasonal allergic rhinitis patients, treated for 14 days. The proportion of these 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.

Questions about international / national guidelines inclusion

We expect that Dymista® will be included in the next British Society of Allergy & Clinical Immunology (BSACI) guidelines and the allergic rhinitis and its impact on asthma (ARIA) guidelines.

Questions on the unmet medical need

No. Current monotherapy does not provide sufficient control in many patients. A survey of 990 allergic patients recruited by 161 GPs in France found that the vast majority of treated patients remain symptomatic. 89% continued to experience rhinorrhea, 82% sneezing, 82% congestion, 68% itching and 68% continued to experience ocular symptoms.

Patients continue to experience symptoms, even those using multiple therapies. A survey of 1,000 seasonal allergic rhinitis patients in the UK found that 96.2% of moderate/severe patients surveyed were on AR medication. However, these patients remained symptomatic with a mean rTNSS of 12.8 (range 0-24) and a mean rTOSS of 8.6 (range 0-18) despite the fact that most (70.5%) were taking 2 or more medications (most notably intranasal corticosteroids plus oral antihistamines).

Between 2006 and 2010 there were four entries into the allergic rhinitis market; however, the physician- and patient-surveys still indicate that no substantial improvement in patient quality of life has been gained.

UK/DYM/14/0070(1) Date of Prep: February 2017

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