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Priority Review Designation Granted for Heron’s HTX-011

If approved, the medication may offer more effective postoperative pain management

A PPM Brief

Heron Therapeutics (San Diego, CA) announced1 that FDA has accepted its NDA and granted Priority Review designation to the investigational agent HTX-011. The extended-release formulation includes the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam and is aimed at helping to manage postoperative pain. According to the company, the agent is the first and only dual-action fixed-combination product specifically designed to address both postoperative pain and inflammation in a single administration.

“We believe that HTX-011 could have a considerable impact on the lives of patients by significantly reducing the proportion of patients who experience severe pain and receive opioids after surgery, especially at discharge,” said Barry D. Quart, PharmD, CEO of Heron Therapeutics, in a release.

If approved, the medication may offer more effective postoperative pain management. (Source: 123RF)

Submitted to FDA in October 2018, the NDA for HTX-011 comprises data from five Phase 2 clinical trials and two Phase 3 clinical trials. The agency previously granted Breakthrough Therapy designation for the agent based on the results of studies which showed that HTX-011 produced significant reductions in pain intensity and the need for opioids through 72 hours post-surgery compared to placebo and bupivacaine solution (the standard-of-care).

“There is a significant need for safe, effective and non-addictive options that can decrease opioid exposure and improve the patient recovery experience, as well as make an impact on the opioid epidemic by significantly reducing the amount of opioids necessary to take home for pain management,” said Jay Redan, MD, FACS, medical director for minimally invasive general surgery at Florida Hospital-Celebration Health, in the Heron release.

The overall safety profile of HTX-011 is similar to that of the bupivacaine solution, without meloxicam-related toxicities such as stomach pain, nausea, headache, dizziness, somnolence, itching, peripheral edema and hypersensitivity. FDA has set a PDUFA date of April 30, 2019.

Last updated on: January 16, 2019
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