Is Ryaltris (olopatadine hydrochloride and mometasone furoate) approved for use in patients under 12 years old in Canada?

Ryaltris (Olopatadine/Mometasone) Approval Status for Children Under 12 in Canada

Ryaltris (olopatadine hydrochloride and mometasone furoate) is not approved for use in patients under 12 years old in Canada.

Approval Status and Age Restrictions

Ryaltris is a fixed-dose combination nasal spray that contains:

• Olopatadine hydrochloride (antihistamine component)
• Mometasone furoate (corticosteroid component)

Clinical studies supporting Ryaltris use have primarily been conducted in patients 12 years and older, with safety and efficacy data specifically demonstrating benefits in adolescents and adults 1, 2. While there is emerging research on its use in younger populations, regulatory approval in Canada currently restricts its use to patients 12 years and older.

Evidence for Age Restrictions

The age restrictions for combination nasal sprays like Ryaltris align with the established safety profiles of similar medications:

• Clinical trials evaluating GSP301 (the development name for Ryaltris) in patients ≥12 years demonstrated efficacy and safety, but these initial approval studies did not include younger children 1, 2

• More recently, a 2022 study specifically evaluated GSP301 in children aged 6-11 years with seasonal allergic rhinitis, showing favorable efficacy and safety 3. However, this newer pediatric data has not yet resulted in regulatory approval for this age group in Canada.

Alternative Treatment Options for Children Under 12

For children under 12 years with allergic rhinitis in Canada, several approved options exist:

1. Intranasal Corticosteroids:

   • Mometasone furoate (Nasonex) - approved for children ≥2 years 4, 5
   • Fluticasone propionate (Flonase) - approved for children ≥4 years 4, 5
   • Triamcinolone acetonide (Nasacort) - approved for children ≥2 years 4

2. Intranasal Antihistamines:

   • Some intranasal antihistamines have age-specific approvals, but most are not approved for very young children

Clinical Implications

When treating allergic rhinitis in children under 12 years:

• Intranasal corticosteroids remain the first-line treatment for allergic rhinitis in children, with fluticasone propionate or mometasone furoate being preferred options due to their established safety profiles and regulatory approval for younger age groups 5

• The American Academy of Otolaryngology-Head and Neck Surgery recommends determining severity and persistence of symptoms when selecting treatment, with intranasal corticosteroids recommended for moderate-severe or persistent symptoms 5

• For mild, intermittent symptoms in children under 12, second-generation oral antihistamines may be used as needed 5

Future Considerations

Recent research suggests that Ryaltris may eventually receive approval for younger age groups:

• A 2022 study demonstrated that GSP301 (Ryaltris) was efficacious and well-tolerated in children aged 6-11 years with seasonal allergic rhinitis 3

• This emerging evidence may lead to future regulatory changes, but clinicians must adhere to current approved age restrictions until formal approval is granted

Until regulatory approval is extended to younger age groups, clinicians should continue using age-appropriate alternatives with established safety and efficacy profiles in children under 12 years old.