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Second phase I abuse liability trial of intranasally administered benzhydrocodone/paracetamol (KP 201)

Trial Profile

Second phase I abuse liability trial of intranasally administered benzhydrocodone/paracetamol (KP 201)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 24 Mar 2023

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At a glance

  • Drugs Benzhydrocodone/paracetamol (Primary) ; Hydrocodone/paracetamol
  • Indications Pain
  • Focus Adverse reactions
  • Sponsors Zevra Therapeutics
  • Most Recent Events

    • 22 Feb 2023 According to a KemPharm media release, KemPharm has changed its name to Zevra Therapeutics.
    • 07 Jan 2019 According to a KemPharm media release, the U.S. Food and Drug Administration (FDA) has approved a Supplemental New Drug Application (sNDA) for two additional strengths of APADAZ, benzhydrocodone, and acetaminophen (APAP). New dosage strengths, 4.08 mg benzhydrocodone/325 mg APAP and 8.16 mg benzhydrocodone/325 mg APAP, follows the New Drug Application (NDA) approval on February 23, 2018 of the 6.12 mg benzhydrocodone/325 mg APAP dosage strength of APADAZ.
    • 23 Feb 2018 According to a KemPharm media release, the U.S. Food and Drug Administration (FDA) has approved New Drug Application (NDA) for Apadaz for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
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