[{"orgOrder":0,"company":"Heron Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Heron Therapeutics Begins Phase 1b\/2 Study of HTX-034 to Treat Postoperative Pain","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Heron Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Heron Therapeutics Announces Publication of Results From Phase 2b Study of HTX-011 in Patients Undergoing Total Knee Arthroplasty","therapeuticArea":"Orthopedics\/Orthopedic Surgery","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Orthopedics\/Orthopedic Surgery","graph2":"Phase II"},{"orgOrder":0,"company":"Heron Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Heron Therapeutics Announces Initiation of Phase 2 Clinical Study of CINVANTI\u00ae for the Treatment of COVID-19","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Heron Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Heron Therapeutics Receives Positive CHMP Opinion for ZYNRELEF\u2122 (HTX-011) for the Management of Postoperative Pain","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Heron Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Heron Therapeutics Announces Successful Outcome of FDA Type A Meeting to Discuss HTX-011 for the Management of Postoperative Pain","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Heron Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Heron Therapeutics Announces Publication of Results of Phase 2b Study of HTX-011 in Patients Undergoing Hernia Repair Surgery","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Heron Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Heron Therapeutics\u2019 Zynrelef Receives European Marketing Approval to Treat Postoperative Pain","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Heron Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Heron Therapeutics Resubmits New Drug Application to FDA for HTX-011 for the Treatment of Postoperative Pain","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Heron Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Heron Therapeutics Announces U.S. FDA Approval of ZYNRELEF\u2122 (HTX-011) for the Management of Postoperative Pain for up to 72 Hours","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Heron Therapeutics","sponsor":"J. Wood Capital Advisors LLC","pharmaFlowCategory":"D","amount":"$150.0 million","upfrontCash":"Undisclosed","newsHeadline":"Heron Therapeutics Announces $150 Million Convertible Debt Financing","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Heron Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Heron Therapeutics Announces Publication of Results from HOPE Trial for ZYNRELEF\u2122","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Heron Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Heron Therapeutics Announces Approval of ZYNRELEF\u00ae by Health Canada for the Management of Postoperative Pain","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Heron Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Heron Therapeutics Presents ZYNRELEF\u00ae Data at the Society for Obstetric Anesthesia and Perinatology 54th Annual Meeting","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Heron Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Heron Therapeutics Announces Publication Showing ZYNRELEF\u00ae as the Foundation of a Perioperative Non-Opioid Multimodal Analgesic Regimen Reduced Severe Pain and Opioid Use in Patients Undergoing Total Knee Arthroplasty","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Heron Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Heron Therapeutics Announces U.S. FDA Approval of APONVIE\u2122 (HTX-019) for the Prevention of Postoperative Nausea and Vomiting (PONV)","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Approved"},{"orgOrder":0,"company":"Heron Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Heron Therapeutics Announces Filing of an Efficacy Supplement for ZYNRELEF\u00ae and Provision in Newly Passed Congressional Bill Anticipated to Provide Separate Reimbursement Outside of the Packaged Surgical Payment for ZYNRELEF","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Heron Therapeutics","sponsor":"CrossLink Life Sciences","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Heron Therapeutics Announces Partnership with CrossLink Life Sciences to Expand Promotional Effort for ZYNRELEF\u00ae, the First and Only Non-Opioid Dual Acting Local Anesthetic for Post-Operative Pain","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals by Heron Therapeutics
The partnership aims to expand the sales network supporting Zynrelef (bupivacaine and meloxicam) extended-release solution, the first and only dual-acting local anesthetic, for post-operative pain.
ZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam.
Administered via a single 30-second IV injection, APONVIE(aprepitant) reaches drug levels associated with ≥97% receptor occupancy in the brain within five minutes and maintains therapeutic plasma concentrations for at least 48 hours.
ZYNRELEF (bupivacaine) is first and only therapy for pain management to be rigorously tested demonstrated superiority to bupivacaine solution, and sustained postoperative pain relief for up to 72 hours and decreased need for opioids, with more patients opioid-free.
New interim data from Phase 2 study suggests ZYNRELEF (bupivacaine) was well-tolerated and may effectively manage postpartum pain and minimize postoperative opioid use in women undergoing Caesarean sections.
ZYNRELEF is first and only therapy of dual-acting fixed-dose combination of local anesthetic bupivacaine and a low dose of meloxicam, for postoperative pain management to be rigorously tested in Phase 3 studies and demonstrate superiority to bupivacaine solution.
ZYNRELEF is an extended-release solution of bupivacaine and meloxicam that is indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty.
Proceeds from the sale of the Notes will be used for the commercial launch of ZYNRELEFTM (bupivacaine and meloxicam) extended-release solution, as well as for general working capital.
ZYNRELEF, the first and only extended-release dual-acting local anesthetic (DALA), delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam.
The NDA for HTX-011 was resubmitted based on the outcome and final minutes of a Type A End-of-Review meeting with the FDA in September, which was conducted to obtain clarity on the information needed to address the Complete Response Letter (CRL) issued by the FDA in June 2020.
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