SAN DIEGO, Sept. 8, 2020 /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 a successful Type A meeting with the U.S. Food and Drug Administration (FDA) in which alignment was reached on the plans for the Company to resubmit the New Drug Application (NDA) for HTX-011 for the management of postoperative pain in the fourth quarter of this year.
HTX-011 is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. Itis 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 solution, the current standard–of–care local anesthetic for postoperative pain control.
"Our Type A meeting with the FDA was extremely constructive, with alignment on next steps for the HTX-011 NDA resubmission and with both parties committed to bringing this important non-opioid analgesic to patients in the U.S. as soon as possible. The FDA responded very positively to the information that Heron has generated to resolve the issues contained in the Complete Response Letter and agreed that the proposed specification change was acceptable," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron. "We expect to resubmit the HTX-011 NDA in the next few months and appreciate the FDA's commitment to an expeditious review for this Breakthrough Therapy product."