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HTX-011 (ZYNRELEF)

Under development for management of postoperative pain

HTX-011 (bupivacaine and meloxicam) is an investigational drug that has not been approved by the FDA. 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 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).

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 in June 2020, relating to non‑clinical information. No clinical safety or efficacy issues and no chemistry, manufacturing and controls (CMC) issues were identified. Heron resubmitted an NDA to the FDA for HTX-011 in November 2020 and the FDA set a Prescription Drug User Fee Act goal date of May 12, 2021. In April 2021, Heron responded to a list of questions received from Health Canada and we anticipate up to a 300-day review period following screening of the response. In September 2020, the European Commission (EC) granted a marketing authorization for ZYNRELEF (also known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. As of January 1, 2021, ZYNRELEF is approved in 31 European countries including the countries of the European Union and European Economic Area and the United Kingdom.

*ZYNRELEF is the approved trade name for HTX-011 in the European Union and the UK.

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