Advances in pharmacotherapy for the treatment of allergic rhinitis; MP29-02 (a novel formulation of azelastine hydrochloride and fluticasone propionate in an advanced delivery system) fills the gaps

Abstract

Introduction: Effective pharmacologic treatment exists for most patients suffering from allergic rhinitis (AR). However, both in clinical trials and in real-life studies, many patients are dissatisfied with treatment. Physicians often use multiple therapies, in an attempt to improve symptom control, often with limited evidence of success. Novel treatment options are needed and must consider unmet medical needs.

Areas covered: This article reviews the clinical data for a new AR treatment. MP29-02 (Dymista®, Meda, Solna, Sweden) contains azelastine hydrochloride (AZE) and fluticasone propionate (FP), in a novel formulation and delivered in an improved device as a single nasal spray. It has shown superior efficacy in AR patients than either commercially available AZE or FP monotherapy for both nasal and ocular symptom relief, regardless of disease severity. MP29-02 also provided more effective and rapid symptom relief than either AZE or FP monotherapy delivered in the MP29-02 formulation and device. However, the effect was less than that observed versus commercial comparators, suggesting the impact of formulation and device on clinical efficacy.

Expert opinion: MP29-02 simplifies AR management, surpassing the efficacy of gold standard treatment, intranasal corticosteroids (INS), for the first time. It is indicated for the treatment of moderate-to-severe seasonal allergic rhinitis and perennial allergic rhinitis when monotherapy with either intranasal antihistamine or INS is NOT considered sufficient. Most patients present with moderate/severe disease, with evidence of current or previous treatment insufficiency. MP29-02 should be the treatment of choice for these patients.

Keywords:

• allergic rhinitis
• ARIA
• azelastine
• fluticasone
• MP29-02
• treatment

Acknowledgement

We thank R Murray from MedScript Ltd Dundalk Ireland for assistance in editing this manuscript.

Declaration of interest

J Bernstein has acted as PI and consultant for Meda. J Bousquet has received honoraria for: Scientific and advisory boards – Almirall, Meda, Merck, MSD, Novartis, Sanofi-Aventis, Takeda, Teva, Uriach. Lectures during meetings – Almirall, AstraZeneca, Chiesi, GSK, Meda, Menarini, Merck, MSD, Novartis, Sanofi-Aventis, Takeda, Teva, Uriach. Board of Directors – Stallergènes. GW Canonica has been speaker and panelist at advisory Boards for Meda. W Carr has acted as consultant for AstraZeneca, Teva, Meda, Noven Pharma, Aerocrine, Allergan, Alcon, Boerhringer Ingelheim, Merck, Mylan, Speakers bureau for AstraZeneca, Teva, Meda, Aerocrine, Allergan, Alcon, Merck, Mylan, Clinical Study investigator for AstraZeneca, Teva, Meda, Novum, Merck, Sanofi, Novartis, Prospero, Merck. R Dahl in past 3 years has received compensation for consulting with ALK-Abello, Boehringer Ingelheim, Cipla, Novartis, Vectura. He has undertaken research funded by ALK-Abello, Boehringer Ingelheim, Chiesi, GlaxoSmithKline (GSK), Novartis and has participated in educational activities sponsored by ALK-Abello, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Meda, Novartis, Teva. P Demoly is a consultant and a speaker for Stallergènes, ALK, Circassia and Chiesi and a speaker for Allergopharma, Merck, AstraZeneca, Menarini and GSK. He has been an investigator for Menarini, Pierre Fabre Médicaments, Stallergènes and ALK. D Ryan has provided consultancy to Uriach, Novartis. He has spoken at meetings on behalf of Novartis, GSK, Meda. He has received sponsorship to attend meetings from: Novartis, Meda, Almirall, Chiesi and AstraZeneca. P Devillier has received consulting fees from GSK, Schering-Plough, AstraZeneca, Almirall, Chiesi, Stallergènes, MedaPharma, Menarini and research grants from Novartis, Sanofi-Aventis, Pierre Fabre. P Hellings is the recipient of an unrestricted research grant by Meda for an academic study, and has given lectures for Meda on MP29-02. L Klimek has been on speakers bureau for ALK-Abello, Allergopharma, Bionorica, Boehringer Ingelheim, GSK, Lofarma, Novartis, Meda, MSD, Phadia, Optima and Clinical Study investigator for ALK-Abello, Allergopharma, Artu-Biologicals, Bencard, Bionorica, Biomay, Cytos, HAL, Hartington, GSK, Leti, Lofarma, Novartis, Roxall. P Lieberman is consultant for Meda, Mylan, Teva, Merck, Genentech and Speaker for Meda, Mylan, Merck, Genentech and has received Research Grants from Novartis, AstraZeneca. D Price has Board Membership for Aerocrine, Almirall, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Meda, Mundipharma, Napp, Novartis and Teva. Received consultancy for Almirall, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Meda, Mundipharma, Napp, Novartis, Pfizer and Teva. Received grants/grants pending from the UK National Health Service, British Lung Foundation, Aerocrine, AstraZeneca, Boehringer Ingelheim, Chiesi, Eli Lilly, GSK, Meda, Merck, Mundipharma, Novartis, Orion, Pfizer, Respiratory Effectiveness Group, Takeda, Teva and Zentiva. Received payments for lectures/speaking from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GSK, Kyorin, Meda, Merck, Mundipharma, Novartis, Pfizer, SkyePharma, Takeda and Teva – Payment for manuscript preparation from Mundipharma and Teva and has patents (planned, pending or issued) with AKL Ltd. He has received payment for the development of educational materials from GSK, Novartis. He has shares in AKL Ltd, owns 80% of research in Real Life Ltd and its subsidiary social enterprise Optimum Patient Care. He has received payment for travel/accommodations/meeting expenses: Aerocrine, Boehringer Ingelheim, Mundipharma, Napp, Novartis and Teva. Funding for patient enrolment or completion of research has been received from Almirall, Chiesi, Teva and Zentiva. Peer reviewer for grant committees: Medical Research Council (2014), Efficacy and Mechanism Evaluation Programme (2012), HTA (2014) – Unrestricted funding for investigator-initiated studies have been received from Aerocrine, AKL Ltd, Almirall, Boehringer Ingelheim, Chiesi, Meda, Mundipharma, Napp, Novartis, Orion, Takeda, Teva, Zentiva. U Wahn consulted for Meda, Novartis and received lecture honoraria from MSD, and Novartis. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

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