Business
Heron Therapeutics Highlights Progress in Pain Management and CINV Franchises and Announces New Development Program
- Preliminary Full-Year 2020 Net Product Sales for CINV Franchise of Approximately $88.3 Million, versus Guidance of $85 Million - - Full-Year 2021 Net
About this update from Heron Therapeutics, Inc.
[{"type":"text","content":"- Preliminary Full-Year 2020 Net Product Sales for CINV Franchise of Approximately $88.3 Million, versus Guidance of $85 Million -\n - Full-Year 2021 Net Product Sales Guidance for CINV Franchise of $130 Million to $145 Million -\n - New Drug Application for HTX-011 for Postoperative Pain Management is Under Review in the US with a May 12, 2021 PDUFA Date -\n - Preliminary Results From Phase 1b Bunionectomy Study with HTX-034 Shows Pain Reduction Through 96 Hours with 45.5% of Patients Opioid-Free Through Day 15 -\n - Preliminary Results from Phase 1 Study of Low Dose HTX-019 IV Injection Demonstrated Bioequivalence to Approved Oral Aprepitant 40 mg Dose for Prevention of Postoperative Nausea and Vomiting -\n\n\nSAN DIEGO, Jan. 11, 2021 /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 highlights progress in its pain management and chemotherapy-induced nausea and vomiting (CINV) franchises and announces a new development program for postoperative nausea and vomiting (PONV).\nRecent Corporate Progress\nPain Management Franchise\nNew Drug Application Resubmission for HTX-011 Under Review: The New Drug Application (NDA) resubmission for HTX-011, an investigational agent for the management of postoperative pain, submitted November 12, 2020 to the U.S. Food and Drug Administration (FDA), continues under review. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of May 12, 2021.Low Dose HTX-034 Produced Greater Pain Reduction to Bupivacaine, the Current Standard-of-Care, Through 96 hours in Bunionectomy Study: In the Phase 1b portion of this Phase 1b/2 double-blind, randomized, active-controlled dose-escalation study in 33 patients undergoing bunionectomy, the reduction in pain intensity observed with the lowest dose of HTX-034 evaluated (containing 21.7 mg of bupivacaine plus meloxicam and aprepitant) was greater than the bupivacaine 50 mg solution group through 96 hours.In addition, 45.5% of HTX-034 patients remained opioid-free through Day 15 with median opioid consumption of 2.5 milligram morphine equivalents (same as one 5 mg oxycodone pill) through 72-hours, a 71% reduction compared to bupivacaine solution. The expanded Phase...