Heron Therapeutics, Inc. Announces Results of Multi-Center Postoperative Pain Management Study of HTX-011
January 03, 2019 at 07:00 pm IST
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Heron Therapeutics, Inc. announced results of a multi-center postoperative pain management study in which 63 patients undergoing hernia repair surgery received the investigational agent, HTX-011, together with a regimen of generic over-the-counter oral analgesics. Designed as a follow-up to the Phase 3 study in hernia repair completed in 2018, this study included many of the same investigators and the same entry criteria as the Phase 3 study. The goal of the current study was to increase the proportion of opioid-free patients by combining HTX-011 with a regimen of readily available, oral analgesics. Topline results of the study include the following: 90% of patients receiving HTX-011 with the OTC analgesic regimen did not require opioids to manage their postoperative pain through 72 hours post-surgery, compared to 51%, 40% and 22% of patients receiving HTX-011, bupivacaine and placebo, respectively, in the prior Phase 3 study. 81% of patients receiving HTX-011 with the OTC analgesic regimen remained opioid-free throu gh 28 days post-surgery. Over 72 hours post-surgery, patients receiving HTX-011 plus the OTC analgesic regimen consumed an average of 0.9 morphine milligram equivalents (MME), which compares to 10.8 MME, 14.5 MME and 17.5 MME for patients receiving HTX-011, bupivacaine and placebo, respectively, in the prior Phase 3 study. HTX-011, which utilizes Heron's proprietary Biochronomer® drug delivery technology, is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain. By delivering sustained levels of both a potent anesthetic and a local anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. HTX-011 has been shown to reduce pain significantly better than placebo or bupivacaine alone in five diverse surgical models: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation. HTX-011 was granted Fast Track designation from the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. Heron submitted a New Drug Application (NDA) to the FDA for HTX-011 in October of 2018 and received Priority Review designation in December of 2018. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of April 30, 2019.
Heron Therapeutics, Inc. is a commercial-stage biotechnology company. The Company commercializes a portfolio of products to care for acute care and oncology patients. Its oncology care product portfolio includes SUSTOL and CINVANTI. SUSTOL is used for the prevention of acute and delayed nausea and vomiting associated with both moderately emetogenic chemotherapy (MEC), and anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. CINVANTI is an intravenous (IV) formulation of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist. Its acute care product portfolio includes ZYNRELEF and APONVIE. HTX- ZYNRELEF is a dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of the nonsteroidal anti-inflammatory drug meloxicam. APONVIE is the IV formulation of a NK1 receptor antagonist indicated for postoperative nausea and vomiting (PONV). Its products are distributed in the United States.