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?

A Phase 3, Randomized, Double Blind, Saline Placebo and Active Controlled, Multicenter Study of HTX 011 Via Local Administration for Postoperative Analgesia and Decreased Opioid Use Following Unilateral Simple Bunionectomy

Trial Profile

A Phase 3, Randomized, Double Blind, Saline Placebo and Active Controlled, Multicenter Study of HTX 011 Via Local Administration for Postoperative Analgesia and Decreased Opioid Use Following Unilateral Simple Bunionectomy

Completed
Phase of Trial: Phase III

Latest Information Update: 31 Dec 2018

At a glance

  • Drugs Bupivacaine/meloxicam (Primary) ; Bupivacaine
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Heron Therapeutics
  • Most Recent Events

    • 31 Dec 2018 According to a Heron Therapeutics media release, based on the results of the five Phase 2 clinical trials and two Phase 3 clinical trials ( HTX011-301 and HTX011-302 ), the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for HTX-011 for the postoperative pain. The FDA has set a Prescription Drug User Fee Act goal date of April 30, 2019.
    • 31 Oct 2018 According to a Heron Therapeutics media release, based on the results of the completed seven clinical studies including phase 3 HTX011-301 and HTX011-302 studies, the company has submitted the NDA to the US FDA for HTX-011 in the management of postoperative pain.
    • 21 Jun 2018 According to the Heron Therapeutics media release, HTX-011 for postoperative pain management has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA), based on the results from this and other study (700280379).
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