3 December 2019 - Heron Therapeutics today announced that Heron's new drug submission for HTX-011 for the management of postoperative pain was granted Priority Review status and accepted by Health Canada.
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.
HTX-011, an investigational agent, is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam.