Heron Therapeutics Inc. (NASDAQ: HRTX) stock surged by 11.38% at last close while the HRTX stock price gains by 7.53% in the pre-market trading session. Heron Therapeutics is an advertising biotechnology business dedicated to improving patients’ lives by discovering best-in-class therapies for some of the most serious unmet medical needs.
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HRTX stock’ Significant Update
The company reported that FDA has accepted a supplemental New Drug Application (sNDA) for ZYNRELEF (bupivacaine and meloxicam) extended-release solution, allowing the company to dramatically broaden the indication. ZYNRELEF is now approved for soft tissue or periarticular installation in adults to provide up to 72 hours of postsurgical analgesia.
ZYNRELEF is the first-ever medication for surgical pain control that has been carefully examined in Phase 3 studies and shown to be better than the existing regular solution, bupivacaine solution. When contrasted to bupivacaine solution, ZYNRELEF provided greater, prolonged postoperative pain management for up to 72 hours and reduced the requirement for opioids, with more patients opioid-free. The FDA has validated that ZYNRELEF’s better efficacy exhibited in pivotal trials justifies its use in a larger spectrum of related surgical procedures with its approval.
ZYNRELEF’s increased indication will now cover about 7 million treatments each year. The use of ZYNRELEF in additional treatments allows doctors to minimize their patients’ requirement for opioids after surgery, which can have a good influence on the individuals and limit postoperative opioids that can contribute to overuse.
Postoperative opioids have been proved to be a gateway to addiction, with more than 2 million American citizens becoming chronic opioid users as a result of getting opioids after the operation. The largest number of fatal overdoses on record happened during the 12-month period ending April 2021, as per the Centers for Disease Control and Prevention, with over 100,000 Americans losing their lives.
Heron aims to file a new sNDA to the FDA in the second half of 2022 to establish a broad indication for soft tissue and orthopaedic surgical procedures, covering the complete 14 million target operations.