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Heron Therapeutics Presents ZYNRELEF® Data at the Society for Obstetric Anesthesia and Perinatology 54th Annual Meeting
- New interim data from Phase 2 study suggests ZYNRELEF was well-tolerated and may effectively manage postpartum pain and minimize postoperative opioid use in
About this update from Heron Therapeutics, Inc.
[{"type":"text","content":"- New interim data from Phase 2 study suggests ZYNRELEF was well-tolerated and may effectively manage postpartum pain and minimize postoperative opioid use in women undergoing Caesarean sections -\nSAN DIEGO, May 16, 2022 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care, today presented at the Society for Obstetric Anesthesia and Perinatology (SOAP) 54th Annual Meeting results from a Phase 2 open-label, multi-cohort study evaluating interim safety and efficacy of ZYRNELEF (bupivacaine and meloxicam) extended-release solution administered postpartum to women undergoing a planned Caesarean section (C-section). ZYNRELEF is currently approved by the U.S. Food and Drug Administration (FDA) for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures.\nThe primary objective of this 25-patient study was to characterize the pharmacokinetics (PK) of the active ingredients and excipients of ZYNRELEF in breast milk and/or plasma following postpartum administration of ZYNRELEF 300 mg/9 mg in Cohort 1 and 400 mg/12 mg in Cohort 2 to women undergoing a planned C-section who did not intend to breastfeed. Overall, a single postpartum dose of ZYNRELEF resulted in very low (microgram) levels of bupivacaine and meloxicam in breast milk. Levels of the well-known excipient dimethyl sulfoxide (DMSO) were barely detectable by 48 hours.\nThe secondary objective was to assess the safety of ZYNRELEF and an exploratory objective was to characterize its efficacy in women undergoing C-section. Results from the study indicate that ZYNRELEF was well-tolerated across both the 300 mg/9 mg and 400 mg/12 mg doses tested. The data also suggest that ZYNRELEF 400 mg/12 mg may effectively manage postpartum pain and minimize postoperative opioid use. In the study, patients given ZYNRELEF 400 mg/12 mg with a scheduled postoperative oral non-opioid multimodal analgesia (MMA) regimen had pain scores in the mild range and 27% had an opioid-free recovery. These patients also requested 69% less opioid rescue medication for pain c...