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)

Completed
Phase of Trial: Phase I

Latest Information Update: 12 Sep 2017

At a glance

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

    • 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.
    • 05 May 2016 According to a KemPharm media release, the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the US FDA voted in favor of approval for benzhydrocodone/paracetamol hydrochloride combination (Apadaz) for the management of acute pain that requires opioid and voted against inclusion of abuse deterrent labeling for the product.
    • 14 Mar 2016 According to a KemPharm Inc. media release, the company's NDA for benzhydrocodone/paracetamol (KP201/APAP) was accepted and granted priority review by the FDA in early February 2016. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 9, 2016.
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