Azelastine nasal spray: the treatment of choice for allergic rhinitis

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1 PRESS RELEASE Azelastine nasal spray: the treatment of choice for allergic rhinitis An astonishing one quarter of the planet s population suffers from allergic rhinitis, living with the aggravating symptoms of rhinorrhea, nasal congestion, frequent sneezing, and intense itching of the mucosal lining of the eyes, nose, ears and throat. These symptoms are not only irritating, but also restrict daily activities and reduce patients quality of life. Left untreated, the inflammation associated with allergic rhinitis can eventually travel down to the lower respiratory tract, developing into asthma, a process referred to as an allergic march by the experts. According to ARIA * the goals of rhinitis treatment include: unimpaired sleep, ability to undertake normal daily activities, no troublesome symptoms and no or minimal side-effects of treatment. There are many different classes of medication currently available to treat the signs and symptoms of rhinitis, but some are more effective than others. A recently published article by Sardana and colleagues in reported that the second-generation antihistamine nasal spray azelastine (Allergodil * ) provided the greatest overall benefit in alleviating symptoms associated with allergic rhinitis when compared to the leukotriene receptor antagonist (LTRA) montelukast or the intranasal corticosteroid budesonide. Azelastine was particularly effective for treating the irritating and common symptom of rhinorrhea, being significantly superior in this regard to either mometasone or intranasal budesonide. Azelastine, which is applied topically as a nasal spray, is effective, fast-acting (relieving all symptoms within 15 minutes), well-tolerated and can be used on an as-needed basis for the treatment of both allergic and non-allergic rhinitis in adults and children. Allergic rhinitis is a common inflammatory disorder of the upper respiratory tract, affecting approximately a quarter of the world s population. This figure looks set to rise in the future due to the complex interplay between changing global climate and genetic susceptibility. Symptoms of allergic rhinitis comprise rhinorrhea (a runny nose), nasal congestion, sneezing, watery eyes, as well as itchiness of the mucosae of the 1 P a g e

2 nose, eyes and throat. These symptoms can appear seasonally in conjugation with pollen release (i.e. seasonal allergic rhinitis) or, for unfortunate sufferers, can be present all the year round (i.e. perennial allergic rhinitis) as a consequence of non-seasonal allergens such as moulds and pet dander. Due to the variety and various combinations of symptoms experienced by allergic rhinitis sufferers, it is not surprising that there are many different types of medication available to treat them. Treatment guidelines from the Joint Task Force (a US panel of different asthma associations), the World Health Organisation (WHO) and ARIA ** all recommend antihistamines (both topical and oral) for the first-line therapy of patients with allergic rhinitis. But how justified is this recommendation of anti-histamines as firstline therapy? A recently published article by Sardana and colleagues 1, from Penn State University in the USA, sought to answer that question. They compared the efficacy of three different classes of medication in three identical studies with identical designs in reducing the individual symptoms of patients with allergic rhinitis. The rhinitis therapies compared included budesonide (an intranasal corticosteroid), montelukast (a LTRA) and azelastine (a potent topical anti-histamine), and were selected based on the lack of clinical research data comparing them. The studies lasted for 8 weeks, had a doubleblind, placebo-control, crossover design, and included adult patients with perennial rhinitis. In order to compare the three active treatments, patients individual and total rhinitis symptoms were given a severity rating. The classification of severity of nasal symptoms is essential for the choice of treatment strategies and the evaluation of treatment outcomes, including the efficacy of anti-allergic drugs in allergic rhinitis. In the Sardana et al 1 study Individual and total rhinitis symptoms were scored according to the well-recognised Rhinitis Severity Score (RSS) which assesses the quality of symptoms specifically associated with runny nose, nasal stuffiness, sneezing, itching/watery eyes, and itching nose/throat/plate/ears. Individual rhinitis symptoms were rated on a 4-point scale with 0, 1, 2 and 3 referring to no symptoms, mild symptoms, moderate symptoms and severe symptoms respectively. The results of the study confirmed that not all anti-rhinitis medications are equal. Intranasal budesonide, montelukast and azelastine nasal spray, differ not only in their mechanisms of action, but also in how effective they are at treating individual 2 P a g e

3 symptoms. The authors concluded that,..it is apparent that azelastine has the greatest overall benefits in alleviating symptoms associated with allergic rhinitis. Azelastine was significantly more effective at reducing rhinorrhea than montelukast. 1 This was an unexpected result as leukotrienes are well-known as extremely potent secretory agents and, thus, it was expected that montelukast would provide a similar reduction of rhinorrhea as azelastine. Azelastine also showed an improvement in total RSS over montelukast, although this does not reach statistical significance. Conversely, the ocular symptoms of itching/watery eyes appeared to respond better (although not significantly so) to montelukast than to azelastine nasal spray. 1 However, it is worth noting that azelastine has also been formulated as eye drops, which take only 3 minutes to relieve red and itchy eyes. 2 A topical treatment like azelastine nasal spray has numerous advantages over an orally administered medication such as montelukast. Firstly, with topical application, medication can be delivered directly to the site of inflammation. Secondly, direct application means that higher drug concentrations can be achieved compared with that achievable with systemic drugs. Finally, the risk of interaction with concomitant medication and the potential for systemic adverse events are minimized with topical application. 3 In the study by Saldana and colleagues, 1 the comparison of azelastine nasal spray with intranasal budesonide yielded similar results to those found with montelukast. Patients who took azelastine reported significantly superior reduction in rhinorrhea compared to those patients who used intranasal budesonide. The total symptom score also favoured azelastine nasal spray. This is an exciting observation, as most previously published studies have shown that topical nasal corticosteroids are the superior agents for all symptoms, but the Saldana data 1 suggest that this is not always the case, especially when symptoms are compared individually. The benefits of azelastine over intranasal corticosteroids have previously been reported by Patel and colleagues in the American Journal of Rhinology. 4 In that study the benefit of azelastine was apparent within 15 minutes and persisted for the entire 8 hour allergen challenge. By contrast mometasone had no effect on nasal symptoms even after eight hours. 4 Azelastine nasal spray has also demonstrated comparable efficacy to the potent intranasal corticosteroid fluticasone propionate both in terms of reduction of rhinitis symptoms and improvement in patient quality of life, but achieved these effects much more rapidly. 5 3 P a g e

4 As well as the significantly superior efficacy of azelastine over intranasal budesonide reported in the US study 1, azelastine nasal spray has other advantages over intranasal corticosteroids such as a faster onset of action 4 and flexibility of both dose (i.e. one or two sprays per nostril twice daily) and dosage (i.e. fixed dose or as-needed). These properties of intranasal azelastine mean that patients can effectively tailor their treatment to suit their own individual needs. The as-needed option means that patients need only take azelastine when their symptoms arise, and with the fast onset of action (15 mins) 6 and long duration of action of azelastine(12 hours) 7, achieve immediate and long-lasting symptom relief. This is not the case with intranasal corticosteroids which need to be applied one to four weeks prior to the expected start of the rhinitis season in order to achieve optimal efficacy. Taken together, these data suggest that topical antihistamines, LTRAs and intranasal corticosteroids all lead to improvement in the symptoms of allergic rhinitis; however, azelastine seems to be the most effective overall. References 1. Sardana N, et al. Allergy Asthma 2010;31(1): Friedlaender MH, et al. Opthalmology 2000;107: Horak F and Zieglmayer UP. Exp Rev Clin Immunol 2009;5: Patel P, et al. Am J Rhinol 2007;21: Behncke VB, et al. J Allergy Clin Immunol 2006;117: Horak F et al. Curr Med Res Opin 2006;22: Greiff L, et al. Clin Exp Allergy 1997;27: * Allergodil is a trademark of MEDA Pharma GmbH & Co KG ** Allergic Rhinitis and its Impact on Asthma 4 P a g e

5 Further information: AzelastinENews: A new newsletter about allergic rhinitis which will provide patients with a new opportunity to obtain recent and helpful information about their affliction. AzelastinENews will be published four times per year in English, Spanish, Italian, French, Polish and Czech. The newsletter can be subscribed to on the azelastine internet portal characters (including spaces and headings, without additional information). Reprints free of charge; sample copies appreciated. For medical Questions Please contact: Dr. Larisa Leibersperger MEDA Pharma GmbH & Co. KG Benzstrasse Bad Homburg Germany Tel.: larisa.leibersperger@medapharma.de MEDA AB (publ) is a leading international specialty pharma company. Meda s products are sold in 120 countries worldwide and the company is represented by its own organizations in more than 50 countries. The Meda share is listed under Large Cap on the Nasdaq OMX Nordic Stock Exchange in Stockholm. To find out more, visit MEDA Pharma GmbH & Co. KG Domicile: Bad Homburg v.d.h. Local district court: Bad Homburg v.d.h.; HRA 4628 Partner reliable to unlimited extent: MEDA Verwaltungs GmbH Amtsgericht Bad Homburg v.d.h.; HRB 9810 Managing Directors: Dr. Jörg-Thomas Dierks, Hans-Jürgen Kromp 5 P a g e