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Heron Therapeutics Announces Financial Results for the Three and Six Months Ended June 30, 2019 and Highlights Recent Corporate Updates
SAN DIEGO, Aug. 5, 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, Aug. 5, 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 financial results for the three and six months ended June 30, 2019 and highlighted recent corporate updates.\nRecent Corporate Updates\nPain Management Franchise\nComplete Response Letter Received from the FDA Regarding the NDA for HTX-011: A Complete Response Letter (CRL) was received from the U.S. Food and Drug Administration (FDA) on April 30, 2019 regarding the Company's New Drug Application (NDA) for HTX-011 for postoperative pain management. The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional Chemistry, Manufacturing and Controls (CMC) and non-clinical information. Based on the complete review of the NDA, the FDA did not identify any clinical safety or efficacy issues, and there is no requirement for further clinical studies or data analyses. 95% of Postoperative Patients Remain Opioid-Free when HTX-011 Is Given with an Over-the-Counter Analgesic Regimen in Real-world Study in Hernia Repair Surgery: In May 2019, we announced the results of a multi-center postoperative pain management study in 93 patients that provides real-world evidence of opioid-free recovery in patients undergoing outpatient inguinal hernia repair surgery who received the investigational agent, HTX-011, together with a scheduled background regimen of generic over-the-counter (OTC) oral analgesics (acetaminophen and ibuprofen). Ninety-one percent (91%) of patients receiving HTX-011 with the OTC analgesic regimen were discharged without an opioid prescription, and none of these patients subsequently requested an opioid for postoperative pain. Results of Phase 3 EPOCH 1 Study Published: In May 2019, the results from the pivotal Phase 3 EPOCH 1 bunionectomy study of HTX-011 were published by the Regional Anesthesia & Pain Medicine journal.CINV Franchise \nCINV 2019 Net Product Sales: For the three months ended June 30, 2019, chemotherapy-induced nausea and vomiting (CINV) franchise net product sales were $36.7 million, up 112% from the same period in 2018, and up 16% from the three months ended March 31, 2019. For the six ...