Bioequivalence of benzhydrocodone/paracetamol (KP 201) versus hydrocodone/paracetamol (Norco) in volunteers

Trial Profile

Bioequivalence of benzhydrocodone/paracetamol (KP 201) versus hydrocodone/paracetamol (Norco) in volunteers

Completed
Phase of Trial: Phase I

Latest Information Update: 05 May 2016

At a glance

  • Drugs Benzhydrocodone/paracetamol (Primary) ; Hydrocodone/paracetamol
  • Indications Acute pain
  • Focus Pharmacokinetics; Registrational
  • Most Recent Events

    • 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.
    • 10 Mar 2016 According to a KemPharm media release, the company has submitted an NDA under the 505(b)(2) regulatory pathway to the US FDA. The FDA has accepted the NDA, granted priority review and assigned a PDUFA date of June 9, 2016.
    • 30 Sep 2013 New trial record
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