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A Double-Blind, Randomized, Parallel-Group Seasonal Allergic Rhinitis (SAR) Study to Evaluate the Efficacy, Safety and Tolerability of GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Olopatadine Hydrochloride Nasal Spray and Mometasone Furoate Nasal Spray) in Adult and Adolescent Subjects (12 Years of Age and Older)

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Trial Profile

A Double-Blind, Randomized, Parallel-Group Seasonal Allergic Rhinitis (SAR) Study to Evaluate the Efficacy, Safety and Tolerability of GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Olopatadine Hydrochloride Nasal Spray and Mometasone Furoate Nasal Spray) in Adult and Adolescent Subjects (12 Years of Age and Older)

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.
    • 22 Mar 2019 Results published in the Annals of Allergy, Asthma and Immunology

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