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Phase I single-centre, placebo-controlled abuse liability trial of orally administered benzhydrocodone/paracetamol (KP 201), compared with hydrocodone/paracetamol.

Trial Profile

Phase I single-centre, placebo-controlled abuse liability trial of orally administered benzhydrocodone/paracetamol (KP 201), compared with hydrocodone/paracetamol.

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 07 Jan 2019

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At a glance

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

    • 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.
    • 12 Sep 2017 According to a company media release, KemPharm has responded to the Complete Response Letter (CRL) received on June 13, 2016 by submitting an amended New Drug Application (NDA) for Apadaz. The FDA has notified the Company with the determination that the NDA application for Apadaz is complete and has assigned February 23, 2018 as the expected date by which an approval decision will be determined.
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