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?

Pivotal bioequivalence trial of modified vs original REMOXY [oxycodone extended-release capsules].

Next Previous
X
Search
Trial Profile

Pivotal bioequivalence trial of modified vs original REMOXY [oxycodone extended-release capsules].

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 10 Jul 2019

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
  • Sponsors Pfizer

    • Most Recent Events

    • 06 Aug 2018 According to a Pain Therapeutics media release, company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for REMOXY. According to the FDA, the data submitted in the NDA do not support the conclusion that the benefits of [REMOXY] Extended-Release Capsules outweigh the risks.
    • 26 Jun 2018 In a joint meeting of 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), majority of the members (14/3) voted against the approval of oxycodone controlled-release capsules 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, according to a Pain Therapeutics media release.
    • 11 May 2015 Status changed from not yet recruiting to completed, as reported in a Pain Therapeutics media release.

You need to be a logged in or subscribed to view this content Request demo

If your organization or you do not have a subscription, try one of the following:
  • Contacting your organization’s admin about adding this content to your AdisInsight subscription
  • Buying a PDF version of any individual profile
  • Request a free trial
If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top