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Phase 3 Study of Intranasal Metoclopramide in Women With Symptomatic Diabetic Gastroparesis

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Trial Profile

Phase 3 Study of Intranasal Metoclopramide in Women With Symptomatic Diabetic Gastroparesis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Metoclopramide (Primary)
  • Indications Diabetic gastroparesis
  • Focus Registrational; Therapeutic Use
  • Sponsors Evoke Pharma
  • Most Recent Events

    • 19 Jun 2020 According to an Evoke Pharma media release, U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for GIMOTI(metoclopramide) nasal spray, the first and only nasally-administered product indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
    • 23 Jan 2020 According to an Evoke Pharma media release, the U.S. Food and Drug Administration (FDA) has set a target goal date under the Prescription Drug User Fee Act (PDUFA) of June 19, 2020.
    • 20 Dec 2019 According to an Evoke Pharma media release, the resubmission includes 3-month stability data from commercial scale registration batches that met all product specifications and support the proposed acceptance criteria for performance characteristics and device quality control and includes data from an analysis of pump performance characteristics for the product used in the comparative bioavailability study and the product from commercial scale registration batches.
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