HTX-011 (bupivacaine and meloxicam) is an investigational drug that has not been approved by the FDA or other international regulatory authority. HTX-011 is in development to reduce postoperative pain for 72 hours and reduce the need for opioid analgesics. It is an extended-release, dual-acting local anesthetic™ (DALA™) applied into the surgical site. It utilizes a novel, synergistic mechanism of action that combines bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam.
HTX-011 is the first and only non-opioid under review for postoperative pain management to receive all 3 FDA designations intended to expedite review of new drugs. The FDA designations include Fast Track meaning it has the potential to address life-threatening conditions and unmet medical needs, Breakthrough Therapy as it could be a substantial improvement over existing therapies, and Priority Review as it may be a significant advancement in treatment. Heron has conducted the Phase 3 clinical trials EPOCH 1 (bunionectomy) and EPOCH 2 (herniorrhaphy), a Phase 2b trial in total knee arthroplasty, and follow-on studies in each of these models in which HTX-011 patients were treated with an additional scheduled postoperative regimen of oral non-opioid analgesics. Heron is conducting The HOPE (Helping Opioid Prescription Elimination) Project evaluating HTX-011 as the foundation of non-opioid multimodal analgesia (MMA).
In 2019, Heron submitted marketing applications for HTX-011 in the US, European Union, and Canada. Heron submitted a New Drug Application (NDA) to the FDA for HTX-011 in October of 2018. A Complete Response Letter (CRL) was received from the FDA regarding the NDA for HTX-011 on June 26, 2020, relating to non-clinical information. No clinical safety or efficacy issues and no chemistry, manufacturing, and controls (CMC) issues were identified. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for ZYNRELEF in July 2020. Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was granted Priority Review status by Health Canada in October 2019 and accepted by Health Canada in November 2019. Heron is working to respond to a list of questions received from Health Canada in July 2020.