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A Double-Blind, Randomized, Parallel-Group Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Two Placebo Nasal Spray Formulations in Subjects (Aged 12 Years and Older) With Perennial Allergic Rhinitis (PAR)

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Trial Profile

A Double-Blind, Randomized, Parallel-Group Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Two Placebo Nasal Spray Formulations in Subjects (Aged 12 Years and Older) With Perennial Allergic Rhinitis (PAR)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Feb 2020

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At a glance

  • Drugs Mometasone/olopatadine (Primary)
  • Indications Perennial allergic rhinitis
  • Focus Adverse reactions; Registrational
  • Sponsors Glenmark Pharmaceuticals S.A.

    • Most Recent Events

    • 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.
    • 15 Nov 2018 According to a Glenmark Pharmaceuticals media release, the companys NDA for Ryaltris is under review with U.S. FDA and the Prescription Drug User Fee Act (PDUFA) target action date for completion of the FDA review is 21 Mar 2019.
    • 15 Nov 2018 According to a Glenmark Pharmaceuticals media release, long term safety and efficacy data from this trial will be presented at the American College of Allergy, Asthma and Immunology Annual Scientific Meeting 2018 (ACAAI 2018) (Seattle, Washington).
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