HRTX - Heron Therapeutics submits HTX-019 application to FDA for prevention of PONV
Heron Therapeutics (NASDAQ:HRTX) announces the submission of its New Drug Application (NDA) to the FDA for HTX-019 (aprepitant) injectable emulsion for the prevention of postoperative nausea and vomiting (PONV) in adults. The NDA filing includes data demonstrating the bioequivalence of HTX-019 32 mg as a 30-second IV injection to oral aprepitant 40 mg, supporting its efficacy for the prevention of PONV. Results also showed HTX-019 was well-tolerated with a similar safety profile compared to oral aprepitant.
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Heron Therapeutics submits HTX-019 application to FDA for prevention of PONV