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

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

Expert Opin Drug Saf. 2015 Nov 19;

Authors: Klimek L, Jean B, David P

Abstract
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. Area 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 50 years ago. It is a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP) 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, 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- and long-term as well as in real life.

PMID: 26581312 [PubMed - as supplied by publisher]

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