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. An NDA for HTX-011 was resubmitted to the FDA in September 2019 with a Prescription Drug User Fee Act (PDUFA) goal date of March 26, 2020. A Marketing Authorisation Application (MAA) for HTX-011 was validated by the European Medicines Agency (EMA) in March 2019 for review under the Centralised Procedure. Heron's New Drug Submission (NDS) for HTX-011 was granted Priority Review status by Health Canada in October 2019 and accepted by Health Canada in November 2019.