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A single-center, Phase 1, randomized, double-blind, placebo-controlled, single-dose, 5-way crossover, Human Abuse Potential Trial of Oral Serdexmethylphenidate

Trial Profile

A single-center, Phase 1, randomized, double-blind, placebo-controlled, single-dose, 5-way crossover, Human Abuse Potential Trial of Oral Serdexmethylphenidate

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 11 Apr 2019

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At a glance

  • Drugs Serdexmethylphenidate (Primary) ; Methylphenidate; Phentermine
  • Indications Attention-deficit hyperactivity disorder
  • Focus Pharmacodynamics; Pharmacokinetics; 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.
    • 18 Jan 2019 According to a KemParma media release, data from this study will be presented at the 2019 Annual Meeting of the American Professional Society for ADHD and Related Disorders (APSARD).
    • 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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