Drug Profile


Alternative Names: KP-201; KP201/IR (acetaminophen-free); KP201/IR (APAP-free)

Latest Information Update: 15 Mar 2017

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At a glance

  • Originator KemPharm
  • Class Benzoates; Epoxy compounds; Morphinans; Opioid analgesics; Small molecules
  • Mechanism of Action Opioid receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Phase I Acute pain

Most Recent Events

  • 20 Dec 2016 Benzhydrocodone receives Fast Track designation for Acute pain [Intranasal] in USA
  • 29 Nov 2016 US FDA accepts IND application for benzhydrocodone (KP 201/IR) in Acute pain
  • 25 Oct 2016 KemPharm files an IND application with the FDA in USA for Acute pain
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