title: Safety evaluation of MP29-02 (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate) for allergic rhinitis.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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 50 years 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: a Department of Otorhinolaryngology , Zentrum für Rhinologie und Allergologie , An den Quellen 10 D-65183 , Wiesbaden , Germany.
authors.forename: Ludger
authors.initials: L
authors.lastname: Klimek
authors.affiliation: b Department of Pneumology , University of Montpellier - Hopital Arnaud de Villeneuve , Montpellier , France.
authors.forename: Jean
authors.initials: J
authors.lastname: Bousquet
authors.affiliation: c General Practice Airways Group Professor of Primary Care Respiratory Medicine, Department of General Practice and Primary Care, Foresterhill Health Centre , University of Aberdeen , Westburn Road, Aberdeen AB25 2AY , UK.
authors.forename: David
authors.initials: D
authors.lastname: Price
mesh_terms: D000281:Administration, Intranasal; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D000818:Animals; D018926:Anti-Allergic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D001682:Biological Availability; D004338:Drug Combinations; D006801:Humans; D010793:Phthalazines / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D065631:Rhinitis, Allergic / Q000188:drug therapy*; D013997:Time Factors
chemical_list: D000730:Androstadienes; D018926:Anti-Allergic Agents; D004338:Drug Combinations; C573864:MP29-02; D010793:Phthalazines
keywords: Dymista; MP29-02; allergic rhinitis; azelastine; fluticasone propionate; safety