A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Adaptive Design, Single-Dose Study of Intravenous N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery.

Trial Profile

A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Adaptive Design, Single-Dose Study of Intravenous N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery.

Completed
Phase of Trial: Phase II

Latest Information Update: 27 Feb 2018

At a glance

  • Drugs Meloxicam (Primary) ; Ibuprofen
  • Indications Dental pain; Postoperative pain
  • Focus Therapeutic Use
  • Sponsors Alkermes plc
  • Most Recent Events

    • 27 Feb 2018 According to a Recro Pharma media release, the New Drug Application (NDA) for intravenous (IV) meloxicam 30mg for the treatment of moderate to severe, acute postoperative pain has been accepted by the FDA in October 2017 and the FDA has assigned a PDUFA date of 26 May 2018.
    • 17 Jan 2018 Results presented in a Recro Pharma media release.
    • 12 Jan 2018 Results published in the Journal of Clinical Pharmacology
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