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

Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Aug 2019

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At a glance

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

    • 08 Aug 2019 According to an Evoke Pharma media release, the FDA did not request additional human clinical trials be completed for NDA resubmission.
    • 08 Aug 2019 According to an Evoke Pharma media release, based on FDA feedback and the meeting minutes, the Company will include its root cause analysis and previously collected patient use and experience information in its resubmission package. The Company agreed to provide an analysis of pump performance characteristics of the nasal spray devices used in the comparative bioavailability study and 3-month stability data from commercial scale batches of Gimoti.
    • 08 Aug 2019 According to an Evoke Pharma media release, following receipt of U.S. Food and Drug Administration (FDA) minutes from a type A meeting held on July 25, 2019, the Company intends to resubmit its New Drug Application (NDA) for Gimoti™ in the fourth quarter of 2019.
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