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Heron Announces European Medicines Agency Validation of Marketing Authorisation Application for HTX-011 for Postoperative Pain Management
SAN DIEGO, April 1, 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, April 1, 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 that the Marketing Authorisation Application (MAA) for its investigational agent, HTX-011, for postoperative pain, was validated by the European Medicines Agency (EMA). Validation of the MAA confirms that the submission is complete and starts the EMA's Centralised Procedure. The EMA granted eligibility to the Centralised Procedure for HTX-011 based on it meeting the criteria of a medicinal product constituting a significant scientific innovation. The Centralised Procedure allows applicants to receive a marketing authorisation that is valid throughout the European Union (EU). With the validation of the MAA, an opinion from the EMA Committee for Medicinal Products for Human Use (CHMP) would be anticipated in the first half of 2020.\nHTX-011 is the first and only dual-acting local anesthetic. HTX-011's novel mechanism of action combines bupivacaine with low-dose meloxicam to overcome the challenges of the inflammatory process at the surgical site. HTX-011 has significantly reduced severe pain and the need for opioids better than standard-of-care bupivacaine solution over 72 hours following surgery. \nThe MAA for HTX-011 is supported by data from 7 completed Phase 2 and Phase 3 studies in more than 1,000 subjects across 5 different surgical models, which are also included in the New Drug Application (NDA) Heron submitted to the U.S. Food and Drug Administration (FDA).\nHTX-011 is the only non-opioid pain medication to have been granted Fast Track designation, Breakthrough Therapy designation and Priority Review designation by the FDA. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of April 30, 2019 for the HTX-011 NDA.\n\"Improved post-operative pain management remains as much an unmet need in Europe as elsewhere,\" said Professor Richard Langford, Lead Consultant in Pain Medicine, The London Clinic and Chief Medical Officer, St Pancras Clinical Research. \"Too many patients still report unacceptable levels of pain after surgery and side effects from opioids, resulting in delayed discharge and recovery and increasing the risk of complication...