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Hydrocodone/paracetamol - Acura Pharmaceuticals

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Drug Profile

Hydrocodone/paracetamol - Acura Pharmaceuticals

Alternative Names: Acetaminophen/hydrocodone; Acetaminophen/hydrocodone bitartrate; Aversion H&A; Hydrocodone bitartrate/acetaminophen; Hydrocodone bitartrate/paracetamol; Hydrocodone/acetaminophen; LTX 03; Paracetamol/hydrocodone; Paracetamol/hydrocodone bitartrate; Vycavert Tablets

Latest Information Update: 06 Feb 2023

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At a glance

  • Originator Acura Pharmaceuticals
  • Class Acetanilides; Morphine derivatives; Non-opioid analgesics; Opioid analgesics; 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.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase II Pain

Most Recent Events

  • 01 Mar 2022 Acura Pharmaceuticals expects the submission and acceptance of NDA in the US FDA by December 2022
  • 01 Oct 2021 Acura Pharmaceuticals received Advice Letter from US FDA for clinical study program of LTX 03
  • 02 Aug 2021 Acura Pharmaceuticals amends its License, Development and Commercialization Agreement regarding LTX 03 with Abuse Deterrent Pharma to extend the FDA Acceptance Date for the product to February 28, 2022.
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