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Heron Therapeutics Announces FDA Acceptance of New Drug Application Resubmission for HTX-011 for Management of Postoperative Pain
SAN DIEGO, Oct. 28, 2019 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of
About this update from Heron Therapeutics, Inc.
[{"type":"text","content":"SAN DIEGO, Oct. 28, 2019 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) resubmission for HTX-011, an investigational agent for the management of postoperative pain. The FDA set a PDUFA goal date of March 26, 2020.\n\"HTX-011 was designated by the FDA as a Breakthrough Therapy for postoperative pain management and has the potential to be an important new pain management option for patients, which has been shown in Phase 3 clinical trials to significantly reduce postoperative pain, including severe pain, and to significantly reduce the need for opioids,\" said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron. \"The recently reported topline results from Study 306 in patients undergoing knee replacement surgery who received HTX-011 as part of a common multimodal analgesic regimen showed that patients maintained an average pain score in the mild range for 72 hours after surgery with only 25% receiving a prescription for opioids upon hospital discharge. These results provide additional evidence that even in large painful surgical procedures HTX-011 can help to reduce both pain and the amount of opioid pills going out into society.\"\n\"There remains a significant need for a new, non-opioid postoperative pain management option that can manage pain through the 72 hours after surgery, when pain is most intense,\" said Roy G. Soto, MD, Director of Education and Anesthesiology Residency Program, Beaumont Health System. \"The surgical setting is a key place we can have a dramatic impact on the opioid crisis, by reducing the amount of opioids used after surgery and, ultimately, the number of unused pills in our homes and communities.\"\nAbout HTX-011 for Postoperative Pain\nHTX-011, an investigational agent, is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine...