Heron Therapeutics

Heron Therapeutics, Inc. is is a public company, based in San Diego, California, USA. Nasdaq ticker HRTX. The company is developing theraphies in acute care and oncology care.

The product pipeline is:

SUSTOL® for Chemotherapy-Induced Nausea and Vomiting Prevention (CINV): U.S. FDA approved as a subcutaneous injection;

CINVANTI® for Chemotherapy-Induced Nausea and Vomiting Prevention (CINV): U.S. FDA approved as a 30-minute intravenous (IV) infusion and a 2-minute IV injection;

ZYNRELEF® for Postoperative Pain Management: Approved in the U.S. and 31 European Countries;

HTX-019 is an IV injectable emulsion formulation designed to directly deliver aprepitant, the active ingredient in EMEND capsules, which is the only Neurokinin 1 receptor antagonist (NK1 RA) to be approved in the United States, for the prevention of postoperative nausea and vomiting (PONV) in adults. The FDA-approved dosing for oral EMEND is 40 mg capsules within 3 hours prior to induction of anesthesia for surgery. In a Phase 1 clinical trial, HTX-019 32 mg as a 30-second IV injection was demonstrated to be bioequivalent to oral aprepitant 40 mg. The NDA for HTX-019 for PONV was submitted in November 2021;

HTX-034 is in development for the treatment of postoperative pain. HTX-034, an investigational non-opioid, is a fixed-dose combination, extended-release solution of the local anesthetic bupivacaine, the nonsteroidal anti-inflammatory drug meloxicam, and an additional agent, aprepitant, that further potentiates the activity of bupivacaine. HTX-034 is formulated in the same proprietary polymer as Heron’s investigational agent ZYNRELEF®. By combining two different mechanisms that each enhance the activity of the local anesthetic bupivacaine, HTX-034 is designed to provide superior and prolonged analgesia. Local administration of HTX-034 in a validated preclinical postoperative pain model resulted in sustained analgesia for 7 days.

In May 2020, Heron announced the clearance of the U.S. Investigational Drug (IND) application for HTX-034 for the treatment of postoperative pain by the Food and Drug Administration. The first-in-human Phase 1b study of HTX-034 in patients undergoing surgery has been completed and the Phase 2 portion of the study started in the first quarter of 2021.

“Heron is truly dedicated to bringing best-in-class treatments to patients in need across multiple disease states.” Chris Flowers– Chris Flowers, Area Business Manager – Oncology Care Sales Force.