First in a new class of treatments, Dymista® shown to be significantly more effective and provide faster symptom relief than two first-line therapies1,2
TORONTO, Oct. 22, 2015 /CNW/ - Meda in Canada today announced that Dymista® Nasal Spray (azelastine hydrochloride/fluticasone propionate) was approved by Health Canada for the symptomatic treatment of moderate-to-severe seasonal allergic rhinitis (SAR) and associated ocular symptoms in adults and adolescents aged 12 years and older for whom monotherapy with either antihistamines or intranasal corticosteroids is not considered sufficient.2
Allergic rhinitis (AR) is an inflammatory disorder which occurs when the membranes lining the nose become sensitized to allergens.3 It affects 20 to 25 per cent of Canadians,4 and is caused by hypersensitivity to allergens, such as grass, weed or tree pollens, animal danders, house dust mites and mould spores.5
"Allergic rhinitis is perhaps the most under-recognized, under-estimated and under-treated chronic condition," says Dr. Paul Keith, Associate Professor, Division of Clinical Immunology and Allergy, Department of Medicine, McMaster University. "Patients have high expectations of their treatment, wanting a rapid onset of action, long duration of effect and substantial relief. Dymista® may be the first real advancement in symptomatic allergic rhinitis management since the introduction of intranasal steroids 50 years ago, and in my opinion, it is a major breakthrough in the management of this condition."
Fast Acting, Effective Symptom Relief2
Dymista® is the first in a new class of SAR treatments to be approved in Canada.1 It has been shown in clinical trials to be significantly more effective than its individual active ingredients (fluticasone propionate alone or azelastine hydrochloride alone) in providing nasal (congestion, nasal itch, rhinorrhea/runny nose and sneezing) and ocular (red, itchy, watery eyes) symptom relief.2
The approval of Dymista® was evaluated in three pivotal randomized, multicenter, double-blind, placebo-controlled clinical trials, involving 848 patients with severe-to-moderate nasal symptoms. In the three pivotal studies, Dymista® was statistically and clinically superior to placebo and the monotherapy components (azelastine hydrochloride alone and fluticasone propionate alone) in reducing the symptoms of SAR, as measured by the combined (daytime plus nighttime) 12-hour reflective total nasal symptom score (rTNSS) over the 14-day study period, the primary endpoint of the studies.2
In those same studies, it was also shown to be statistically and clinically superior to placebo in reducing ocular symptoms of SAR as measured by the combined (daytime plus nighttime) reflective total ocular symptom score.2
Dymista® also improved individual nasal and ocular symptoms, postnasal drip and the patients' disease-related quality of life (Rhinoconjunctivitis Quality of Life Questionnaire – RQLQ) as compared to placebo, azelastine hydrochloride and fluticasone propionate.2
Dymista® also has a rapid onset of action, an important consideration given that current therapies require some time to become effective.6 Across all three studies, subjects who received Dymista® experienced a statistically significant decrease in Total Nasal Symptom Score (TNSS), as compared to placebo, in as early as 30 minutes after the first dose.2
"Allergic rhinitis can be a challenging condition to treat since patients use multiple medications that are often not effective. As a result, this may lead to frustration and discouragement and non-compliance with treatment," says Dr. Martin Desrosiers, Clinical Professor, Program Director, ORL-HNS, Université de Montréal. "Having a treatment, like Dymista®, that provides significant and rapid symptom relief is important to improve patient compliance and quality of life. I recommend Dymista® to many of my patients because it is the best product I have seen to-date."
Adverse events (AEs) occurred with similar frequencies in patients treated with Dymista® compared with either azelastine or fluticasone alone.2 The percentage of subjects with any adverse event was low in all treatment groups.2 Across all treatment groups, the majority of adverse events were mild in nature.2 The most common adverse events were dysgeusia (distortion of sense of taste), epistaxis (nose bleed) and headache.2
About Allergic Rhinitis
Seasonal allergic rhinitis occurs during pollen season with sufferers most affected by trees from mid-March to mid-June, grasses from mid-May to the end of July, and ragweed from mid-August to the first frost.5
Allergic rhinitis can significantly impact quality of life since symptoms can affect social life, sleep, learning and working.5 It is a risk factor for asthma4 and prevalence of the disease is increasing worldwide,5 a trend caused by a variety of factors, such as, changing global climate conditions, improvements in hygiene, changes in diet, and increased obesity.4
About the Three Pivotal Studies (MP-4002, MP-4004, MP-4006)2
The efficacy and safety of Dymista® in SAR was evaluated in three pivotal randomized, multicenter, double-blind, placebo-controlled clinical trials in 760 adults (18-78 years old) and 88 adolescent (12-17 years old) patients with SAR.
Patients with moderate-to-severe nasal symptoms were randomized to one of four treatment groups: one spray per nostril twice-daily of Dymista®, azelastine hydrochloride nasal spray, fluticasone propionate nasal spray, and vehicle placebo. The azelastine hydrochloride and fluticasone propionate comparators use the same device and vehicle as Dymista® Nasal Spray and are not commercially marketed.
The primary endpoint for these studies was the change from baseline in the combination (daytime plus nighttime) 12-hour reflective total nasal symptom score (crTNSS: maximum possible score of 24) over the 14-day study period versus placebo, azelastine or fluticasone propionate alone.
About Meda in Canada
Meda in Canada is the Canadian operation of Meda, a Swedish specialty pharmaceutical company with a global presence and currently present in over 60 countries. Meda is dedicated to providing products that serve society by increasing the well-being and quality of life of patients. Meda's products fall within several therapy areas but the main areas of focus include respiratory (allergies and asthma), dermatology, pain and inflammation. For more information please visit our global website www.meda.se and our Canadian website www.medapharma.ca.
For more information about Dymista®, please visit www.medapharma.ca.
1WHO Collaborating Center for Drug Statistics Methodology. http://www.whocc.no/atc_ddd_index/?code=R01AD58&showdescription=yes Accessed October 21, 2015
2Dymista® Product Monograph. October 17, 2014
3University of Saskatchewan. http://medsask.usask.ca/professional/guidelines/allergic-rhinitis.php Accessed September 22, 2015
4Keith et al. Allergy, Asthma & Clinical Immunology 2012, 8:7
5Allergy, Asthma and Immunology Society of Ontario. http://allergyasthma.on.ca/patient/rhinitis-hay-fever/ Accessed Septemer 22, 2015
6Carr W et al. J Allergy Clin Immunol 2012;129:1282-1289
SOURCE Meda in Canada
For further information: Jeanelle Awa, Environics Communications, 416-969-2670, [email protected]