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A Human Abuse Potential Trial of Intranasal Serdexmethylphenidate

Trial Profile

A Human Abuse Potential Trial of Intranasal Serdexmethylphenidate

Completed
Phase of Trial: Phase I

Latest Information Update: 24 Oct 2018

At a glance

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

    • 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.
    • 17 Sep 2018 According to a KemPharm media release, the company will present the data from all three HAP trials, as well as tampering study results, to the U.S. Food and Drug Administration (FDA) as part of its human abuse potential assessment for SDX in the KP415 New Drug Application (NDA). The NDA filing is anticipated as early as the first quarter of 2019.
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