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
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
- 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).
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History