Pharmacokinetics of intranasal mometasone in the fixed-dose combination GSP301 versus two monotherapy intranasal mometasone formulations

Patel, Piyush M.; Salapatek, Anne Marie; Talluri, Ravi S.; Tantry, Sudeesh K.

doi:10.2500/aap.2018.39.4134

Cited by 21 publications

(10 citation statements)

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“…Of the 4 SAEs that occurred during study treatment, none were considered related to treatment. These results are similar to those observed in several early clinical studies of GSP301 in patients with 22,23 and without SAR, 42,43 in another short-term phase 3 clinical study of patients with SAR, 24 and in a long-term phase 3 study of patients with PAR, 25 confirming that GSP301 has a favorable safety and tolerability profile.…”

Section: Discussionsupporting

confidence: 88%

Efficacy and safety of olopatadine-mometasone combination nasal spray for the treatment of seasonal allergic rhinitis

Gross¹,

Berman

Amar

et al. 2019

Annals of Allergy, Asthma & Immunology

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Background: GSP301 nasal spray is a fixed-dose combination of olopatadine hydrochloride (antihistamine) and mometasone furoate (corticosteroid). Objective: To evaluate the efficacy and safety of GSP301 in patients with seasonal allergic rhinitis (SAR). Methods: In this double-blind study, eligible patients (!12 years of age) with SAR were randomized 1:1:1:1 to twice-daily GSP301 (665 mg of olopatadine and 25 mg of mometasone), olopatadine (665 mg), mometasone (25 mg), or placebo for 14 days. The primary end pointdmean change from baseline in average morning and evening 12-hour reflective Total Nasal Symptom Score (rTNSS)dwas analyzed via a mixed-effect model repeated measures (P < .05 was considered to be statistically significant). Additional assessments included average morning and evening 12-hour instantaneous TNSS (iTNSS), ocular symptoms, individual symptoms, onset of action, quality of life, and adverse events (AEs). Results: A total of 1176 patients were randomized. GSP301 provided statistically significant and clinically meaningful rTNSS improvements vs placebo (least squares mean difference,-1.09; 95% CI,-1.49 to-0.69; P < .001) and vs olopatadine (P ¼ .03) and mometasone (P ¼ .02). Similar significant improvements in iTNSS were also observed with GSP301 (P < .05 for all). Furthermore, GSP301 significantly improved overall ocular symptoms, individual nasal and ocular symptoms, and quality of life vs placebo (P .001 for all). Onset of action for GSP301 was observed within 15 minutes and was maintained at all subsequent timepoints. Treatment-emergent AEs occurred in 15.6%, 12.6%, 9.6%, and 9.5% of patients in the GSP301, olopatadine, mometasone, and placebo groups, respectively. Conclusion: GSP301 is efficacious and well tolerated vs placebo for treating SAR-associated nasal and ocular symptoms, with a rapid onset of action of 15 minutes in adult and adolescent patients 12 years and older. Clinical Trial Registration: ClinicalTrials.gov: NCT02870205.

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Section: Discussionsupporting

confidence: 88%

Efficacy and safety of olopatadine-mometasone combination nasal spray for the treatment of seasonal allergic rhinitis

Gross¹,

Berman

Amar

et al. 2019

Annals of Allergy, Asthma & Immunology

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“…Headache was the most commonly reported TEAE and occurred similarly across treatments (11.1% for twice-daily GSP301 and olopatadine; 8.3% for AzeFlu and placebo) except for a greater incidence in the once-daily GSP301 group (16.7%). In 2 pharmacokinetic studies of GSP301 in healthy participants, 39,40 favorable safety and tolerability profiles were observed with low systemic exposure. Furthermore, in several large, natural allergen exposure studies in SAR, once-daily or twice-daily GSP301 [30][31][32] dosing was well tolerated, with similar incidences of AEs to placebo or component monotherapies.…”

Section: Discussionmentioning

confidence: 99%

Effect of olopatadine-mometasone combination nasal spray on seasonal allergic rhinitis symptoms in an environmental exposure chamber study

Patel

Salapatek

Tantry³

2019

Annals of Allergy, Asthma & Immunology

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Background: GSP301 nasal spray is a fixed-dose combination of the antihistamine olopatadine hydrochloride and the corticosteroid mometasone furoate intended for seasonal allergic rhinitis (SAR) treatment. Objective: To evaluate the efficacy and safety of once-daily or twice-daily GSP301 in a ragweed pollen environmental exposure chamber. Methods: In this randomized, double-blind, double-dummy study, adults (18-65 years old) with SAR were equally randomized to 665 mg of olopatadine and 25 mg of mometasone (twice-daily GSP301), 665 mg of olopatadine and 50 mg of mometasone (once-daily GSP301), a US Food and Drug Administration−approved formulation of 137 mg of azelastine and 50 mg of fluticasone twice-daily (AzeFlu), a US Food and Drug Administration −approved formulation of 665 mg of olopatadine twice-daily, or placebo (twice-daily). During 2 visits (baseline and end of 14-day treatment), participants assessed SAR symptoms at specified time points. The primary end point-mean change from baseline in instantaneous total nasal symptom score (iTNSS) for twice-daily or oncedaily GSP301 vs placebo-was analyzed by analysis of covariance. Onset of action, ocular symptoms, and adverse events were assessed. Results: A total of 180 participants were randomized. Treatment with twice-daily or once-daily GSP301 provided statistically significant improvements in iTNSS vs placebo (twice-daily GSP301: least squares mean difference, ¡3.60; 95% confidence interval [CI], ¡4.89 to ¡2.30; once-daily GSP301: least squares mean difference, ¡3.05; 95% CI, ¡4.35 to ¡1.76; P < .0001 for both). Significant improvements in iTNSS with twice-daily GSP301 occurred by 10 minutes after dosing (¡1.26; 95% CI, ¡2.30 to ¡0.21; P = .02) and were maintained at all later time points except one (2.5 hours). Treatment-emergent adverse events occurred in 22.2%, 30.6%, 25.0%, 22.2%, and 16.7% of participants in the twice-daily GSP301, once-daily GSP301, AzeFlu, olopatadine, and placebo groups, respectively. Conclusion:In an environmental exposure chamber model, twice-daily and once-daily GSP301 treatments were well tolerated and provided statistically significant and clinically meaningful SAR symptom improvement vs placebo. Trial Registration: ClinicalTrials.gov Identifier: NCT03444506

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“…First results show a significant reduction of AR symptoms compared to placebo in a doubleblind pollen chamber study [64]. Studies on the phar-macokinetics of GSP301 have already shown that the fixed combination of olopatadine and mometasone is at least as readily available in a fixed combination as the mono products [65,66].…”

Section: Fixed Combination Of Topical Glucocorticoid and Intranasal Amentioning

confidence: 98%

Therapy of allergic rhinitis in routine care: evidence-based benefit assessment of freely combined use of various active ingredients

et al. 2020

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Pharmacokinetics of intranasal mometasone in the fixed-dose combination GSP301 versus two monotherapy intranasal mometasone formulations

Cited by 21 publications

References 0 publications

Efficacy and safety of olopatadine-mometasone combination nasal spray for the treatment of seasonal allergic rhinitis

Efficacy and safety of olopatadine-mometasone combination nasal spray for the treatment of seasonal allergic rhinitis

Effect of olopatadine-mometasone combination nasal spray on seasonal allergic rhinitis symptoms in an environmental exposure chamber study

Therapy of allergic rhinitis in routine care: evidence-based benefit assessment of freely combined use of various active ingredients

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