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A Double-Blind, Randomized, Parallel-Group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose Combination GSP 301 Nasal Spray (NS) Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators) in Subjects (Aged 12 Years and Older) With Seasonal Allergic Rhinitis (SAR)

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Trial Profile

A Double-Blind, Randomized, Parallel-Group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose Combination GSP 301 Nasal Spray (NS) Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators) in Subjects (Aged 12 Years and Older) With Seasonal Allergic Rhinitis (SAR)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Jan 2022

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At a glance

  • Drugs Mometasone/olopatadine (Primary) ; Mometasone; Olopatadine
  • Indications Seasonal allergic rhinitis
  • Focus Registrational; Therapeutic Use
  • Sponsors Glenmark Pharmaceuticals S.A.

    • Most Recent Events

    • 14 Jan 2022 According to a Glenmark Holding media release, company received FDA approval on its New Drug Application (NDA) for Ryaltris™, an innovative, fixed-dose (metered), prescription, combination drug product nasal spray for the treatment of symptoms of Seasonal Allergic Rhinitis in adults and pediatric patients 12 years of age and older in the United States.
    • 26 Feb 2020 According to a Hikma Pharmaceuticals media release, the FDA issued a Complete Response Letter (CRL) to Glenmark regarding the NDA for Ryaltris in June 2019, citing deficiencies pertaining to the proposed manufacturing facility. The CRL did not specify any deficiencies with the clinical data supporting the NDA for Ryaltris.
    • 25 Feb 2019 Results of a pooled analysis of nasal symptoms and TEAEs from NCT02318303, NCT02631551, NCT02870205 trials, presented at the 2019 Annual Meeting of the American Academy of Allergy, Asthma and Immunology

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