Clinical Report: FDA Expands Pediatric Allergy Nasal Spray Use
Overview
The FDA has expanded the indication for RYALTRIS nasal spray to include pediatric patients aged 6 to younger than 12 years with seasonal allergic rhinitis, according to a press release from Glenmark Specialty S.A. This decision follows a phase 3 trial that enrolled 446 pediatric patients aged 6 to 11 years, which reported greater improvement in nasal symptoms among treated children compared to placebo.
Background
Seasonal allergic rhinitis is a common condition affecting children, leading to significant discomfort and impairment in daily activities. The expansion of RYALTRIS to younger pediatric patients provides a new treatment option for managing this condition.
Data Highlights
| Study Design | Participants | Duration | Outcome |
|---|---|---|---|
| Phase 3, randomized, double-blind, placebo-controlled | 446 pediatric patients aged 6-11 years | 14 days | Improvement in nasal symptoms with RYALTRIS |
Key Findings
- The FDA expanded RYALTRIS indication to include children aged 6 to <12 years.
- RYALTRIS is a fixed-dose combination of olopatadine hydrochloride and mometasone furoate.
- In a clinical trial, RYALTRIS showed greater improvement in nasal symptoms compared to placebo.
- Common adverse reactions included dysgeusia, epistaxis, and nasal discomfort.
- Warnings include potential reduction in growth velocity in pediatric patients.
Clinical Implications
The prescribing information includes warnings and precautions regarding potential reduction in growth velocity in pediatric patients receiving treatment.
Conclusion
The expanded indication for RYALTRIS is supported by evidence from a clinical trial.
Related Resources & Content
- Glenmark Specialty S.A., Press Release, 2026 -- FDA Expands Pediatric Allergy Nasal Spray Use
- ClinicalTrials.gov, 2022 -- Efficacy and Safety of GSP 301 Nasal Spray in Children
- PubMed, 2026 -- Olopatadine plus mometasone for seasonal allergic rhinitis treatment
- MDSpire News — FDA Drops Age Limit for Neffy
- MDSpire News — FDA Approves First Needle-Free Epinephrine for Kids
- MDSpire News — FDA Approves First Nasal Spray for Anaphylaxis
- MDSpire News — FDA Approves Odactra for Pediatric House Dust Mite Allergy
- DailyMed - RYALTRIS
- MDSpire News — FDA Drops Age Limit for Neffy
- MDSpire News — FDA Approves First Needle-Free Epinephrine for Kids
- https://glenmark.b-cdn.net/gpl_pdfs/media/Press%20Release%20-%20Glenmark%20Receives%20U.S.%20FDA%20Approval%20to%20Expand%20Use%20of%20RYALTRIS%20Nasal%20Spray%20to%20Children%20Aged%206%20to%20Less%20Than%2012%20Years.pdf
- Study Results | NCT03463031 | Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR) | ClinicalTrials.gov
- Olopatadine plus mometasone for seasonal allergic rhinitis treatment: A pooled analysis of clinical trials - PubMed
- Intranasal Treatments for Allergic Rhinitis in Preschool- and School-Age Children: Network Meta-Analysis - PubMed
- Allergic Rhinitis and Its Impact on Asthma (ARIA)‐EAACI Guidelines—2024–2025 Revision: Part I—Guidelines on Intranasal Treatments - PMC
- Efficacy and safety of intranasal medications for allergic rhinitis: Network meta-analysis - PubMed
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