HRTX - Heron wins FDA nod for post-operative agent to address nausea and vomiting
- Commercial-stage biotech Heron Therapeutics, Inc. ( NASDAQ: HRTX ) announced Friday that the FDA approved its intravenous injection Aponvie (aprepitant) for the prevention of postoperative nausea and vomiting (PONV) in adults. HRTX shares are currently on hold for trading.
- It is estimated that 30% of patients who have received general anesthesia and up to 80% of high-risk patients experience PONV.
- "This marks an important milestone for our expanding acute care portfolio and is a testament to our ongoing commitment to developing innovative solutions to help improve the overall patient experience after surgery," HRTX Chief Executive Barry Quart noted.
- In Nov. 2021, the company submitted the New Drug Application for Aponvie targeting PONV in adults, and later the FDA accepted the marketing application granting Sep. 17 as the PDUFA date.
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Heron wins FDA nod for post-operative agent to address nausea and vomiting