Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

Phase I open-label, laboratoty-blinded, randomized, crossover trial comparing Rexista oxycodone XR to Oxycontin under single dose fasting conditions

Trial Profile

Phase I open-label, laboratoty-blinded, randomized, crossover trial comparing Rexista oxycodone XR to Oxycontin under single dose fasting conditions

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 23 Jul 2020

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Oxycodone (Primary)
  • Indications Pain
  • Focus Pharmacokinetics; Registrational
  • Most Recent Events

    • 02 Jul 2020 According to an Intellipharmaceutics International media release, company and Purdue Pharmaceuticals entered into a stipulated dismissal agreement to terminate Prude Pharma's patent litigation regarding the NDA filing for oxycodone controlled release with the US FDA, subject to approval by the court.
    • 16 Jan 2020 According to an Intellipharmaceutics International media release, there can be no assurance that the FDA will ultimately approve the NDA for the sale of Aximris XR in the U.S. market, or that it will ever be successfully commercialized.
    • 16 Jan 2020 According to an Intellipharmaceutics International media release, the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) voted to not support the approval of Aximris XR (oxycodone extended-release tablets) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Back to top