4.3 Review

Safety evaluation of MP29-02 (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate) for allergic rhinitis

期刊

EXPERT OPINION ON DRUG SAFETY
卷 15, 期 1, 页码 117-129

出版社

TAYLOR & FRANCIS LTD
DOI: 10.1517/14740338.2016.1122755

关键词

allergic rhinitis; azelastine; Dymista; fluticasone propionate; MP29-02; safety

资金

  1. ALK-Abello
  2. Allergopharma
  3. Bionorica
  4. Dr. Pfleger
  5. Stallergenes
  6. HAL
  7. Artu Biologicals
  8. Allergy Therapeutics/Bencard
  9. Hartington
  10. Lofarma
  11. MEDA
  12. MSD
  13. Novartis/Leti
  14. ROXALL
  15. GSK
  16. Essex-Pharma
  17. Cytos
  18. Curalogic
  19. UK National Health Service
  20. British Lung Foundation
  21. Aerocrine
  22. AKL Ltd
  23. Almirall
  24. AstraZeneca
  25. Boehringer Ingelheim
  26. Chiesi
  27. Eli Lilly
  28. GlaxoSmithKline
  29. Merck
  30. Mundipharma
  31. Napp
  32. Novartis
  33. Orion
  34. Pfizer
  35. Respiratory Effectiveness Group
  36. Takeda
  37. Teva
  38. Zentiva
  39. Cipla
  40. Kyorin
  41. SkyePharma
  42. Medical Research Council
  43. Efficacy and Mechanism Evaluation programme

向作者/读者索取更多资源

Introduction: As a chronic disease, allergic rhinitis (AR) requires regular use of allergy medications for the effective management of symptoms. It is therefore imperative that AR treatments not only provide adequate symptom control but are also well tolerated.Areas covered: MP29-02 (Dymista, Meda, Solna, Sweden) is the first new class of AR medication (WHO ATC R01AD58) since the introduction of intranasal corticosteroids (INS) almost 50years ago. It is a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate delivered in a single spray. Here we review all the safety information relevant to MP29-02, from the initial phase I bioavailability and disposition data, to the phase III 14-day and 52-week data and finally to phase IV safety data collected during MP29-02 use in routine clinical practice.Expert opinion: MP29-02 is the first real therapeutic advance in AR since the introduction of INS and has the potential to change the way this disease is managed, simplifying AR treatment regimens to a single puff in each nostril twice a day. Patients will benefit from superior symptom relief MP29-02 compared to INS with the added assurance that the safety of MP29-02 has been confirmed in the short term and long term as well as in real life.

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