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 Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was granted Priority Review status and accepted by Health Canada.
Editor's Note: This article originally appeared on Heron Therapeutics' website.
Health Canada's Priority Review status provides an accelerated 6-month review target for the NDS. Health Canada grants Priority Review status to drug submissions intended for the treatment, prevention or diagnosis of serious, life-threatening or severely debilitating illnesses or conditions for which there is substantial evidence of clinical effectiveness and a benefit/risk profile that is improved over existing therapies.
"We are appreciative of Health Canada for granting Priority Review status for the HTX-011 NDS," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron. "Priority Review status was granted based on Health Canada's acknowledgement that reduction in opioid prescribing and consumption is an important medical and public health priority and that the benefit/risk profile of HTX-011 is improved over existing therapies based on the results of the two pivotal Phase 3 studies, EPOCH 1 and EPOCH 2, in which HTX-011 demonstrated superior, longer-lasting pain relief compared to bupivacaine with fewer patients using opioid analgesics."
"The overprescribing of opioids after surgery puts surgical patients at risk for opioid-related adverse events and potential long-term use, which can result in unused pills making their way into communities," said Dr. Ken Leslie, Chief, Division of General Surgery, London Health Sciences Centre, London, Ontario, and Principal Investigator of the Standardization of Outpatient Procedure (STOP) Narcotics Study. "New opioid-free options to more effectively manage postoperative pain, while reducing the need for opioids, are urgently needed, as opioid-related deaths have been on the rise in Canada with more than 12,800 apparent opioid-related deaths occurring between January 2016 and March 2019." Click here to continue>>
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