Bunionectomy Study for Postoperative Analgesia (EPOCH 1)

Summary

This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via local administration into the surgical site in subjects undergoing bunionectomy.

Timeline

Start

2017-10-24

Primary completion

2018-01-08

Completion

2018-03-13

Outcome

Met primary endpoint

paper The results for the primary and all four key secondary endpoints were statistically significant in favor of HTX-011. PMID 31113830 ↗

registry Treatment Group 1: HTX-011 vs Treatment Group 2: Saline Placebo; p < 0.0001 NCT03295721 ↗

registry Least Squares Mean Difference (LSMD) -122.05 (95% CI -163.76 to -80.34) NCT03295721 ↗

Publications

• Yip T, Hu J, Hawn PS, Yamamoto A, Oderda G. HTX-011 effectively reduces postoperative pain intensity and opioid use in the elderly. Pain Manag. 2022 Jan;12(1):45-57. doi: 10.2217/pmt-2021-0043. Epub 2021 Jul 21.
• Viscusi E, Gimbel JS, Pollack RA, Hu J, Lee GC. HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in bunionectomy: phase III results from the randomized EPOCH 1 study. Reg Anesth Pain Med. 2019 May 21:rapm-2019-100531. doi: 10.1136/rapm-2019-100531. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bupivacaine	Other / unclassified	50 mg	Other
Subject	Bupivacaine	Other / unclassified	60 mg	Other
Subject	Meloxicam	Small molecule	1.8 mg	Other

Indications

No indication recorded.