FDA approved Ryaltris (olopatadine/mometasone) for Seasonal Allergic RhinitisFDA approved new nasal spray Ryaltris for seasonal allergy symptoms

FDA From the archive Source published January 13, 2022 Summary added July 13, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Ryaltris for patients 12 years and older with seasonal allergic rhinitis who may benefit from combined antihistamine and corticosteroid therapy.

The FDA has approved Ryaltris (olopatadine hydrochloride and mometasone furoate) nasal spray for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older. Ryaltris is a fixed-dose combination of an antihistamine and a corticosteroid, offering a dual mechanism of action in a single nasal spray. The approval was supported by two multicenter, randomized, double-blind, placebo- and active-controlled trials (NCT02631551 and NCT02870205) enrolling 2352 patients. In both studies, Ryaltris demonstrated statistically significant improvements in the reflective total nasal symptom score (rTNSS) compared to placebo and to olopatadine alone; in one study, it also showed superiority over mometasone furoate alone. The recommended dosage is two sprays in each nostril twice daily. Ryaltris provides a new option for patients with seasonal allergic rhinitis who may benefit from combined antihistamine and corticosteroid therapy.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Ryaltris contains olopatadine, a histamine-1 (H1)-receptor inhibitor, and mometasone furoate, a corticosteroid. The combination provides anti-allergic and anti-inflammatory effects.

Indication & Patient Population

Ryaltris is indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older.

Dosing & Administration

For nasal use only. The recommended dosage is 2 sprays in each nostril twice daily (2 sprays deliver a total of 1,330 mcg of olopatadine hydrochloride and 50 mcg of mometasone furoate). Shake the bottle well before each use. Prime before initial use by releasing 6 sprays or until a fine mist appears. When not used for 14 or more days, re-prime by releasing 2 sprays or until a fine mist appears. Avoid spraying into the eyes or mouth.

Key Clinical Trial Data

Efficacy was evaluated in two multicenter, randomized, double-blind, placebo- and active-controlled studies of 2-week duration (Study 1: NCT02631551; Study 2: NCT02870205). A total of 2352 patients 12 years and older with seasonal allergic rhinitis were enrolled. Patients had a history of seasonal allergic rhinitis for at least 2 years, positive skin prick test, and baseline 12-hour rTNSS ≥8 with congestion score ≥2. Patients were randomized to Ryaltris, olopatadine alone, mometasone alone, or placebo. The primary endpoint was change from baseline in average AM and PM 12-hour reflective total nasal symptom score (rTNSS) over 14 days. In both studies, Ryaltris showed statistically significant improvement in rTNSS compared to olopatadine and placebo. Compared to mometasone, Ryaltris showed significant improvement in Study 2 but not in Study 1 (95% CI -0.8 to 0.0).

Warnings & Contraindications

Not reported in label.

Place in Therapy

Ryaltris is a combination nasal spray for seasonal allergic rhinitis in patients 12 years and older. It offers the convenience of a single product with both antihistamine and corticosteroid components. Clinical trials demonstrated superiority over olopatadine alone and, in one study, over mometasone alone.

The FDA has approved a new prescription nasal spray called Ryaltris for seasonal allergies. It combines two medicines: an antihistamine (olopatadine) and a corticosteroid (mometasone furoate). This means it works in two ways to relieve symptoms like sneezing, runny nose, and congestion. Ryaltris is for adults and children aged 12 years and older.

The approval was based on two large studies involving over 2,300 patients. In these studies, Ryaltris improved nasal symptoms better than a placebo and better than the antihistamine alone. In one study, it also worked better than the corticosteroid alone. The recommended dose is two sprays in each nostril twice a day.

This approval offers a new treatment option for people with seasonal allergic rhinitis, commonly known as hay fever. It may be especially helpful for those who need both an antihistamine and a steroid but want a single spray. However, it is not a cure for allergies.

If you have seasonal allergies, talk to your doctor to see if Ryaltris might be right for you. Your doctor can help you understand the benefits and possible side effects based on your health history.

What this means for you:

Ryaltris is a new two-in-one nasal spray for seasonal allergies, but talk to your doctor before using it.

Study Details

Study typeFda approval

PublishedJan 2022

View Original Abstract ↓

1 INDICATIONS AND USAGE RYALTRIS is indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older. RYALTRIS is a combination of olopatadine, a histamine-1 (H1)-receptor inhibitor, and mometasone furoate, a corticosteroid, indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older. ( 1 )

FDA approved Ryaltris (olopatadine/mometasone) for Seasonal Allergic RhinitisFDA approved new nasal spray Ryaltris for seasonal allergy symptoms

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FDA approved Ryaltris (olopatadine/mometasone) for Seasonal Allergic RhinitisFDA approved new nasal spray Ryaltris for seasonal allergy symptoms

Study Details

Budesonide-glycopyrronium-formoterol fumarate dihydrate improved lung function and reduced severe exacerbations versus budesonide-formoterol in inadequately controlled asthma

New Asthma Drug Cuts Attacks Without Recent Crisis

Clinical research that matters. Delivered to your inbox.

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