Benzhydrocodone/paracetamol - KemPharm

Drug Profile

Benzhydrocodone/paracetamol - KemPharm

Alternative Names: Acetaminophen/benzhydrocodone; Acetaminophen/KP-201; Apadaz; APAP/KP-201; Benzhydrocodone and acetaminophen; Benzhydrocodone/acetaminophen; KP-201/acetaminophen; KP-201/APAP; KP201/IR; Paracetamol/benzhydrocodone; Paracetamol/KP-201

Latest Information Update: 26 Feb 2018

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At a glance

  • Originator KemPharm
  • Class Acetanilides; Antipyretics; Benzoates; Epoxy compounds; Morphinans; Non-opioid analgesics; Opioid analgesics; Opioid peptides; Small molecules
  • Mechanism of Action Opioid receptor agonists; Prostaglandin receptor antagonists
  • 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

  • Registered Acute pain

Most Recent Events

  • 23 Feb 2018 Registered for Acute pain in USA (PO)
  • 23 Feb 2018 Benzhydrocodone/paracetamol has a boxed warning for addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; cytochrome P450 3A4 interaction; hepatotoxicity; and risks from concomitant use with benzodiazepines or other CNS depressants
  • 12 Sep 2017 FDA accepts amended NDA and assigns PDUFA action date of 23/02/2018 for benzhydrocodone/paracetamol for Acute pain
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