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Clinical development of an advanced intranasal delivery system of azelastine hydrochloride and fluticasone propionate.
Drugs Today (Barc). 2014 Jan; 50(1):15-31.DT

Abstract

There is no shortage of pharmacologic treatments available for the management of allergic rhinitis (AR), but none regularly provide full relief from all symptoms. MP29-02 (Dymista®) is a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP), benefiting from an enhanced formulation and improved device characteristics compared to marketed intranasal corticosteroid (INS) formulations. Results from large, randomized, double-blind, placebo-controlled, head-to-head trials versus first-line therapies, confirmed MP29-02 as the evidence-based drug-of-choice for AR treatment. MP29-02 was twice as effective as AZE or FP for nasal and ocular symptom relief in moderate to severe seasonal AR patients, with superiority documented regardless of season, and in more severe patients. More MP29-02-treated patients experienced clinically relevant responses (i.e., halving of nasal symptom burden and complete/near-to-complete relief) days faster than those on INS or intranasal antihistamine monotherapy. MP29-02's efficacy was sustained long-term versus FP (up to 52 weeks) in chronic rhinitis patients (perennial AR or nonallergic rhinitis), with 7 out of 10 patients first becoming symptom-free following 1 month's treatment with MP29-02, and days faster than with the INS. These results confirm MP29-02's superiority over the historical gold-standard therapy for AR (i.e., INS), and position it now as first-line treatment for moderate to severe AR patients, the majority of whom are uncontrolled on existing medications.

Authors+Show Affiliations

College of Pharmacy, University of Florida, Gainesville, Florida, USA.Allergy and Asthma Medical Group and Research Center, San Diego, California, USA.Clinical Research Appliance, Gelnhausen, Germany.University of Genova, IRCCS AOU S. Martino, Genoa, Italy. canonica@unige.it.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

24524103

Citation

Derendorf, H, et al. "Clinical Development of an Advanced Intranasal Delivery System of Azelastine Hydrochloride and Fluticasone Propionate." Drugs of Today (Barcelona, Spain : 1998), vol. 50, no. 1, 2014, pp. 15-31.
Derendorf H, Meltzer EO, Hermann R, et al. Clinical development of an advanced intranasal delivery system of azelastine hydrochloride and fluticasone propionate. Drugs Today (Barc). 2014;50(1):15-31.
Derendorf, H., Meltzer, E. O., Hermann, R., & Canonica, G. W. (2014). Clinical development of an advanced intranasal delivery system of azelastine hydrochloride and fluticasone propionate. Drugs of Today (Barcelona, Spain : 1998), 50(1), 15-31. https://doi.org/10.1358/dot.2014.50.1.2094806
Derendorf H, et al. Clinical Development of an Advanced Intranasal Delivery System of Azelastine Hydrochloride and Fluticasone Propionate. Drugs Today (Barc). 2014;50(1):15-31. PubMed PMID: 24524103.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical development of an advanced intranasal delivery system of azelastine hydrochloride and fluticasone propionate. AU - Derendorf,H, AU - Meltzer,E O, AU - Hermann,R, AU - Canonica,G W, PY - 2014/2/14/entrez PY - 2014/2/14/pubmed PY - 2014/2/14/medline KW - Azelastine hydrochloride KW - Burden KW - Chronic rhinitis KW - Fluticasone propionate KW - MP29-02 KW - Seasonal allergic rhinitis SP - 15 EP - 31 JF - Drugs of today (Barcelona, Spain : 1998) JO - Drugs Today (Barc) VL - 50 IS - 1 N2 - There is no shortage of pharmacologic treatments available for the management of allergic rhinitis (AR), but none regularly provide full relief from all symptoms. MP29-02 (Dymista®) is a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP), benefiting from an enhanced formulation and improved device characteristics compared to marketed intranasal corticosteroid (INS) formulations. Results from large, randomized, double-blind, placebo-controlled, head-to-head trials versus first-line therapies, confirmed MP29-02 as the evidence-based drug-of-choice for AR treatment. MP29-02 was twice as effective as AZE or FP for nasal and ocular symptom relief in moderate to severe seasonal AR patients, with superiority documented regardless of season, and in more severe patients. More MP29-02-treated patients experienced clinically relevant responses (i.e., halving of nasal symptom burden and complete/near-to-complete relief) days faster than those on INS or intranasal antihistamine monotherapy. MP29-02's efficacy was sustained long-term versus FP (up to 52 weeks) in chronic rhinitis patients (perennial AR or nonallergic rhinitis), with 7 out of 10 patients first becoming symptom-free following 1 month's treatment with MP29-02, and days faster than with the INS. These results confirm MP29-02's superiority over the historical gold-standard therapy for AR (i.e., INS), and position it now as first-line treatment for moderate to severe AR patients, the majority of whom are uncontrolled on existing medications. SN - 1699-3993 UR - https://www.unboundmedicine.com/medline/citation/24524103/Clinical_development_of_an_advanced_intranasal_delivery_system_of_azelastine_hydrochloride_and_fluticasone_propionate_ L2 - http://journals.prous.com/journals/servlet/xmlxsl/pk_journals.xml_summaryn_pr?p_JournalId=4&p_RefId=2094806 DB - PRIME DP - Unbound Medicine ER -
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