Oxycodone/naltrexone - Elite Pharmaceuticals

Drug Profile

Oxycodone/naltrexone - Elite Pharmaceuticals

Alternative Names: Abuse resistant oxycodone; ELI-200; ELI-201; ELI-216; Naltrexone/oxycodone - Elite Pharmaceuticals; Oxy-Nal; OxyNal™; SequestOx

Latest Information Update: 27 Jan 2017

Price : $50

At a glance

  • Originator Elite Pharmaceuticals
  • Class Analgesics; Cyclopropanes; Drug withdrawal therapies; Morphinans; Morphine derivatives; Opioid analgesics; Small molecules
  • Mechanism of Action Opioid delta receptor agonists; Opioid kappa receptor agonists; Opioid mu receptor agonists; Opioid receptor antagonists
  • Orphan Drug Status

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

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No
  • Available For Licensing Yes - Pain

Highest Development Phases

  • Preregistration Pain
  • Phase III Postoperative pain

Most Recent Events

  • 23 Jan 2017 Elite Pharmaceuticals plans to initiate bridging studies for oxycodone/naltrexone
  • 15 Jul 2016 Elite Pharmaceuticals receives complete response letter from the FDA for ELI 200 in Pain
  • 17 Mar 2016 Planned Prescription Drug User Fee Act (PDUFA) date for Pain in USA (PO) is 2016-07-14
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top