Ryaltris (olopatadine/mometasone) / Glenmark, China Grand Pharma - LARVOL DELTA

Glenmark Pharmaceuticals Ltd. has received approval from China’s National Medical Products Administration for RYALTRIS, a respiratory treatment for allergic rhinitis in adults and children. (Scanx) - "The approval follows successful Phase III clinical trials in China involving 535 patients."

China approval • Allergic Rhinitis

Treatment of allergic rhinitis and allergic conjunctivitis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Allergic Rhinitis • Allergy • Conjunctivitis • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology

Comparison table: Some nasal sprays for seasonal allergic rhinitis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Allergic Rhinitis • Allergy • Immunology • Inflammation

Clinically Relevant Characterization and Comparison of Ryaltris and Other Anti-Allergic Nasal Sprays. (PubMed, Pharmaceutics) - "The work aims to investigate technological aspects of Ryaltris (mometasone furoate and olopatadine hydrochloride nasal spray) compared to other commercial anti-allergic nasal products, namely, Dymista (azelastine hydrochloride and fluticasone propionate), Nasonex (mometasone furoate), and Avamys (fluticasone furoate). Finally, the intranasal deposition profile of the commercial formulations was determined using a silicon nasal cast. The results highlight in vitro significant differences in terms of viscosity as well as dissolution rate of the nasal products, with Ryaltris showing a higher viscosity and lower flow compared to other products, which, along with a corticosteroid faster dissolution rate than Dymista, suggest a potential advantage in terms of clinical behavior."

Journal

Intranasal combo: fixed-dose combination of mometasone furoate and olopatadine hydrochloride in therapeutic strategies for rhinosinusitis. (PubMed, Otolaryngol Pol) - "By combining two preparations with different mechanism of action, this novel approach facilitates quick and effective controls of all upper respiratory tract allergy symptoms. The article presents the results of a study of olopatadine hydrochloride and mometasone furoate fixed-dose combination (GSP301) administered intranasally from a spray formulation, with an attempt at positioning the treatment within the ARIA and EPOS guidelines."

Journal • Allergic Rhinitis • Allergy • Immunology • Inflammation • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Azelastine Allergen Chamber - Onset of Action Study (clinicaltrials.gov) - P2 | N=84 | Completed | Sponsor: MEDA Pharma GmbH & Co. KG | Active, not recruiting ➔ Completed

Trial completion • Allergic Rhinitis • Immunology • Inflammation

Azelastine Allergen Chamber - Onset of Action Study (clinicaltrials.gov) - P2 | N=84 | Active, not recruiting | Sponsor: MEDA Pharma GmbH & Co. KG | Recruiting ➔ Active, not recruiting

Enrollment closed • Allergic Rhinitis • Immunology • Inflammation

Azelastine Allergen Chamber - Onset of Action Study (clinicaltrials.gov) - P2 | N=84 | Recruiting | Sponsor: MEDA Pharma GmbH & Co. KG

New P2 trial • Allergic Rhinitis • Immunology • Inflammation

Intranasal corticosteroid and antihistamine combinations in the treatment of allergic rhinitis: the role of the novel formulation olopatadine/mometasone furoate. (PubMed, Expert Rev Clin Immunol) - "Allergic rhinitis (AR) is a common disease with an important impact on the quality of life and very high management costs. Here, we review the evidence for GSP301, especially concerning the efficacy and safety profile of this intranasal combination in the treatment of AR. The evidence provided in the current review clearly supports the use of GSP301 as a novel INCS/INAH with a well-documented efficacy and safety profile in terms of rapid symptom relief and good tolerability."

Journal • Allergic Rhinitis • Immunology • Inflammation

"New AusPAR for Ryaltris (olopatadine and mometasone furoate) for allergic rhinitis and rhinoconjunctivitis. Read more: https://t.co/jWd6OszTk7" (@TGAgovau)

Allergic Rhinitis • Conjunctivitis • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology

Patient Satisfaction and Sensory Attributes of Nasal Spray Treatments of Olopatadine Hydrochloride/Mometasone Furoate Monohydrate and Azelastine Hydrochloride/Fluticasone Propionate for Allergic Rhinitis in Australia - An Observational Real-World Clinical Study. (PubMed, Patient Prefer Adherence) - "Combination intranasal corticosteroid and antihistamine sprays are a first-line treatment option for allergic rhinitis (AR), of which Azelastine Hydrochloride and Fluticasone Propionate nasal spray (AZE/FLU; Dymista), and Olopatadine Hydrochloride and Mometasone Furoate Monohydrate nasal spray (OLO/MOM; Ryaltris) are currently registered in Australia. Current findings showed that participants using OLO/MOM were more satisfied with their overall treatment compared to participants using AZE/FLU, particularly with sensory attributes, thus highlighting the suitability of OLO/MOM for people with AR who value sensory attributes. Prescribers of AR treatments are encouraged to discuss treatment attributes with patients to facilitate shared decision-making."

Journal • Real-world • Real-world evidence • Allergic Rhinitis • Immunology • Inflammation

Olopatadine/mometasone (Ryaltris) for allergic rhinitis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Allergic Rhinitis • Allergy • Immunology • Inflammation

Intranasal Olopatadi: Mometasone in the Treatment of Seasonal Allergic Rhinitis. (PubMed, Ann Pharmacother) - "The PubMed database and ClinicalTrials.gov were searched using the following terms: mometasone + olopatadine, GSP301, mometasone furoate, and olopatadine hydrochloride. Due to its quick and sustained onset of action, OM may be an ideal agent for initial treatment of moderate-severe SAR for patients 12 years and older. OM significantly improves SAR symptoms and is a viable treatment option in short-term SAR."

Journal • Review • Allergic Rhinitis • Herpes Simplex • Immunology • Infectious Disease • Inflammation • Ocular Infections • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Efficacy and safety of GSP301 nasal spray in children aged 6-11 with seasonal allergic rhinitis. (PubMed, Ann Allergy Asthma Immunol) - P3 | "GSP301 was well tolerated and efficacious for treating SAR symptoms in pediatric subjects and demonstrated a favorable safety profile."

Journal • Allergic Rhinitis • CNS Disorders • Conjunctivitis • Immunology • Infectious Disease • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Pediatrics

Impact of RYALTRIS® Nasal Spray on Patients' Reported Outcomes (clinicaltrials.gov) - P=N/A | N=0 | Withdrawn | Sponsor: Community and Patient Preference Research Pty Ltd | N=100 ➔ 0 | Recruiting ➔ Withdrawn | Trial primary completion date: Dec 2021 ➔ Mar 2022

Enrollment change • Trial primary completion date • Trial withdrawal • Allergic Rhinitis • Immunology • Inflammation

Impact of RYALTRIS® Nasal Spray on Patients' Reported Outcomes (clinicaltrials.gov) - P=N/A; N=100; Recruiting; Sponsor: Community and Patient Preference Research Pty Ltd

Clinical • New trial • Allergic Rhinitis • Immunology

Efficacy and safety of twice-daily olopatadine-mometasone combination nasal spray (GSP301) in the treatment of allergic rhinitis: a systematic review and meta-analysis. (PubMed, Eur Arch Otorhinolaryngol) - "GSP301 is a safe and well-tolerated medication. It showed short-term benefits for seasonal and perennial AR, but may not help to improve patients' quality of life and rhinitis control in the long run."

Journal • Retrospective data • Review • Allergic Rhinitis • Conjunctivitis • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology

[VIRTUAL] Clinically Meaningful Improvement in Total Rhinoconjunctivitis Score with Olopatadine/mometasone Combination Nasal Spray in Patients with Seasonal Allergic Rhinitis: A Pooled Analysis (ERS 2021) - "The objective of this pooled analysis was to demonstrate the clinically meaningful effect of GSP301, a nasal spray combination of olopatadine hydrochloride (OLO) and mometasone furoate (MF), in treating both nasal and ocular symptoms of seasonal allergic rhinitis (SAR). Time to response was significantly faster with GSP301 (30% percentile 4 days) than placebo (10 day, p<0.001), OLO (7 days, p=0.035) and MF (7 days, p=0.017). GSP301 provides a clinically meaningful and statistically significant improvement in total nasal and ocular symptoms compared to individual monotherapies."

Retrospective data • Allergic Rhinitis • Conjunctivitis • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology

Clinically meaningful effect on nasal symptoms and quality of life improvements with olopatadine/mometasone combination nasal spray in patients with seasonal allergic rhinitis: A pooled analysis (EAACI 2021) - P2, P3 | "Background GSP301, a nasal spray combination of olopatadine hydrochloride (antihistamine) and mometasone furoate (corticosteroid), has previously been shown to be efficacious and well-tolerated for the treatment of seasonal allergic rhinitis (SAR). Treatment-emergent adverse events were low and comparable across treatments (reported elsewhere) . Conclusion This shows that GSP301 provides a clinical meaningful response in nasal symptoms in patients with SAR as well as improves QoL."

HEOR • Retrospective data • Allergic Rhinitis • Immunology

Long-term safety and efficacy of olopatadine-mometasone combination nasal spray in patients with perennial allergic rhinitis. (PubMed, Allergy Asthma Proc) - P3 | "Twice-daily GSP301 was well tolerated and provided statistically significant and clinically meaningfulimprovements in PAR nasal symptoms versus placebo over 52 weeks and demonstrated a favorable safety profile and efficacy."

Clinical • Journal • Allergic Rhinitis • Immunology

Olopatadine-mometasone combination nasal spray: Evaluation of efficacy and safety in patients with seasonal allergic rhinitis. (PubMed, Allergy Asthma Proc) - P3 | "GSP301 was efficacious and well tolerated for the treatment of SAR symptoms compared with placebo, witha rapid onset of action of 15 minutes in patients greater than or equal to 12 years of age."

Clinical • Journal • Allergic Rhinitis • Immunology

Efficacy and Safety of Twice-daily and Once-daily Olopatadine-Mometasone Combination Nasal Spray for Seasonal Allergic Rhinitis. (PubMed, Ann Allergy Asthma Immunol) - P2 | "Twice-daily GSP301 treatment was efficacious and well tolerated, providing statistically significant and clinically meaningful improvements in rTNSS (primary endpoint) versus placebo and both monotherapies."

Clinical • Journal

Efficacy and safety of olopatadine/mometasone combination nasal spray for the treatment of seasonal allergic rhinitis. (PubMed, Ann Allergy Asthma Immunol) - P3; "GSP301 nasal spray is a fixed-dose combination of olopatadine hydrochloride (antihistamine) and mometasone furoate (corticosteroid). No abstract available"

Clinical • Journal

Olopatadine/Mometasone Combination Nasal Spray Improves Seasonal Allergic Rhinitis Symptoms in an Environmental Exposure Chamber Study. (PubMed, Ann Allergy Asthma Immunol) - P2; "In an EEC model, GSP301 BID and QD treatments were well tolerated and provided statistically significant and clinically meaningful SAR symptom improvement versus placebo."

Journal