Investigator-Initiated Trials (IITs), Grants, Sponsorships, and Contributions
Heron Therapeutics is committed to supporting programs and activities that inspire best-in-class patient care, medical and scientific education, and patient advocacy.
In alignment with our goals to develop best-in-class medicines for the management of cancer and pain, Heron is focused on initiatives related to the areas of oncology, supportive care oncology, postoperative pain management, and reducing opioid dependence.
Heron will review funding requests from healthcare- or science-related organizations for the following:
- Investigator-Initiated Trials
- Medical Educational Grants (including CME accredited programs)
- Charitable Contributions
As a general guidance for IITs, please note that Heron considers many factors which may include:
- Scientific and medical merit
- Relevant areas of research interest
Within the Pain Product Portfolio, Heron is interested in research studies where HTX-011 (bupivacaine and meloxicam) would be used in conjunction with non-opioid multi-modal postoperative pain management strategies with a goal of reducing the use of opioids, especially in OB/GYN, general surgery, orthopedic, colorectal, and plastics.
As general guidance for grant requests, please note that Heron considers many factors which may include:
- Promotes excellence in patient care
- Meets CME guidelines related to content, venue, and dissemination as applicable
- Is conducive to an effective and efficient meeting format
- Educates the broadest target audience at an appropriate and reasonable cost
Heron is committed to complying with all applicable transparency reporting and disclosure obligations, including those relating to state and federal regulations and as stipulated by the National Physician Payment Transparency Program. At this time, Heron can only accept applications from institutions located within the United States.
To complete a form and submit a proposal for an IIT click here.
To complete a form and submit a proposal for a grant click here.
To complete a form and submit a proposal for a sponsorship or contribution click here.
Please submit any proposals at least 60 days in advance of a program or event for which funding is being requested.
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.