Heron Therapeutics stock surges in pre-market trading
Today, Heron Therapeutics (HRTX) stock surged ~33% in pre-market trading, after the company announced it had received breakthrough designation from the FDA for its postoperative pain management drug, HTX-011. The drug received fast-track designation in November 2017. Heron Therapeutics expects to submit a new drug application for HTX-011 in the second half of this year. The SPDR S&P Biotech ETF (XBI) rose ~2.2%.
Heron Therapeutics’ product portfolio
In addition to HTX-011, Heron Therapeutics has two FDA-approved drugs for chemotherapy-induced nausea and vomiting prevention, Sustol and Cinvanti. The company’s product portfolio is outlined in the above chart.
HTX-011 study results
HTX-011 is an investigational, extended-release, long-acting, fixed-dose formulation of bupivacaine (a local anesthetic) combined with meloxicam (a nonsteroidal anti-inflammatory drug) for postoperative pain management. The FDA gave breakthrough therapy designation to HTX-011 based on recently completed Phase 2 and Phase 3 studies demonstrating that the drug significantly reduced pain intensity and the need for opioid analgesics for 72 hours after surgery.
Opioid analgesics, the most widely used postoperative pain management drugs in the United States, can lead to addiction. According to Heron Therapeutics, 40 million US patients undergo surgery and are prescribed opioid drugs for pain management every year, and ~440,000 of them become addicted to opioids. The company has reported that HTX-011 would be suitable for ~28 million of the surgical procedures requiring postoperative pain management, and it estimates a potential market opportunity of $9.1 billion. Alkermes (ALKS) and Cara Therapeutics (CARA) also develop opioid-free drugs for postoperative pain management.
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