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. It is a fixed-dose combination of the local anesthetic bupivacaine with the nonsteroidal anti-inflammatory drug (NSAID) meloxicam. Inclusion of low-dose meloxicam in HTX-011 reduces local inflammation and reverses the acidic environment caused by surgery, allowing enhanced penetration of bupivacaine into the nerves and thereby potentiating its effect. HTX-011 is in development for application into the surgical site to reduce postoperative pain and the need for opioid analgesics for 72 hours. It was granted Fast Track Designation from the FDA in the fourth quarter of 2017 and Breakthrough Therapy Designation from the FDA in the second quarter of 2018. Heron released positive Topline Phase 3 Results for HTX-011 in the EPOCH 1 study (bunionectomy) and the EPOCH 2 study (hernia repair) and positive Topline Phase 2b Results for HTX-011 in subjects undergoing total knee arthroplasty and breast augmentation. A Complete Response Letter was received from the FDA regarding the NDA for HTX-011 on April 30, 2019 relating to chemistry, manufacturing and controls, and non-clinical information. No issues related to clinical efficacy or safety were noted.
A Marketing Authorisation Application for HTX-011 was validated by the European Medicines Agency in March 2019 for review under the Centralised Procedure.