| Title | Pharmacokinetic characteristics and safety and tolerability of a reformulated azelastine hydrochloride nasal spray in patients with chronic rhinitis. | | Author(s) | Berger WE | | Institution | Department of Pediatrics, Division of Allergy and Immunology, University of California, Irvine, USA. weberger@uci.edu | | Source | Expert Opin Drug Metab Toxicol 2009 Jan; 5(1):91-102. | | MeSH | Administration, Intranasal
Aerosols
Biological Availability
Clinical Trials as Topic
Histamine Antagonists
Humans
Phthalazines
Rhinitis, Allergic, Seasonal
Rhinitis, Vasomotor
Treatment Outcome
| | Abstract | BACKGROUND: Intranasal azelastine hydrochloride (Astelin, Meda Pharmaceuticals, Somerset, NJ, USA) is a first-line treatment for allergic and non-allergic vasomotor rhinitis with well-established therapeutic efficacy and safety. A new formulation of azelastine nasal spray (Astepro, Meda Pharmaceuticals, Somerset, NJ, USA), with a sorbitol-based vehicle and sucralose as a taste-masking agent, was developed to reduce the bitter taste of azelastine experienced by some patients.
OBJECTIVE: Two studies were conducted to evaluate the safety, tolerability and pharmacokinetic parameters of this new formulation compared with the original azelastine nasal spray.
METHODS: In a pharmacokinetic study, 18 healthy volunteers received either a single dose of the new formulation or the original formulation and pharmacokinetic parameters were determined. In a 1-year safety study, patients with chronic rhinitis were randomized to the new formulation (n = 430) or the original formulation (n = 432) to assess tolerability and the potential for adverse effects on the nasal mucosa.
RESULTS/
CONCLUSIONS: The new formulation was safe and well tolerated with long-term use and had a comparable pharmacokinetic profile to the original formulation. The overall incidence of treatment-emergent adverse events with the new formulation (48.4%) and the original formulation (49.1%) was similar, with no evidence of increased nasal irritation, nasal septal perforation, severe epistaxis or ulceration with either formulation during the 1-year study. | | Language | eng | | Pub Type(s) | Journal Article
Review
| | PubMed ID | 19220164 |
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