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A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of DPI-386 Nasal Gel for the Prevention of Nausea and Vomiting Associated With Motion

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of DPI-386 Nasal Gel for the Prevention of Nausea and Vomiting Associated With Motion

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Feb 2024

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At a glance

  • Drugs Scopolamine (Primary)
  • Indications Motion sickness; Nausea and vomiting
  • Focus Registrational; Therapeutic Use
  • Sponsors Repurposed Therapeutics

Most Recent Events

  • 30 Jan 2024 According to a Defender Pharmaceuticals Media Release,company announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the Companys New Drug Application (NDA) for intranasal scopolamine (DPI-386) for the prevention of nausea and vomiting induced by motion in adults.
  • 26 Sep 2023 According to a Defender Pharmaceuticals Media Release, results from this trial were presented at the 2023 Military Health System Research Symposium (MHSRS)
  • 26 Sep 2023 Results presented in the Defender Pharmaceuticals Media Release.

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