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A Human Abuse Potential Trial of Intranasal Serdexmethylphenidate

Trial Profile

A Human Abuse Potential Trial of Intranasal Serdexmethylphenidate

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 11 Apr 2019

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At a glance

  • Drugs Serdexmethylphenidate (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Pharmacodynamics; Registrational
  • Sponsors KemPharm
  • Most Recent Events

    • 11 Apr 2019 According to a KemPharm media release, the company has concluded a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for KP415. The FDA confirmed the clinical and non-clinical requirements for its submission, and the company is now on track for submission in late Q2 or early Q3 2019.
    • 24 Oct 2018 According to a KemPharm media release, data from the study will be presented at the 65th Annual American Academy of Child and Adolescent Psychiatry (AACAP) Meeting 2018.
    • 24 Oct 2018 Results presented in a KemPharm media release.
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