US FDA receives New Drug Application for Heron Therapeutics' CINVANTI.
M2 PHARMA-January 16, 2017-US FDA receives New Drug Application for Heron Therapeutics' CINVANTI
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The US Food and Drug Administration (FDA) has received a New Drug Application from United States-based Heron Therapeutics for its CINVANTI (HTX-019), a polysorbate 80-free, intravenous formulation of aprepitant for the prevention of Chemotherapy-Induced Nausea and Vomiting (CINV), it was reported on Friday.
The New Drug Application filing includes data demonstrating the bioequivalence of CINVANTI to EMEND IV (fosaprepitant), supporting its efficacy for the prevention of both acute and delayed CINV with both moderately emetogenic chemotherapy and highly emetogenic chemotherapy.
Results also indicated that the product was better tolerated than EMEND IV, with significantly fewer adverse events reported with CINVANTI.
The product is a proprietary intravenous formulation of aprepitant, a NK1 receptor antagonist intended for the prevention of CINV. NK1 receptor antagonists are typically used in combination with 5-HT3 receptor antagonists.
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|Date:||Jan 16, 2017|
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