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Heron submits CINVANTI NDA with US FDA for the prevention of CINV.

M2 PHARMA-January 13, 2017-Heron submits CINVANTI NDA with US FDA for the prevention of CINV

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Biotechnology company Heron Therapeutics Inc (Nasdaq:HRTX) said on Thursday that it has filed a New Drug Application (NDA) for CINVANTI (HTX-019) with the US Food and Drug Administration (FDA) for the prevention of Chemotherapy-Induced Nausea and Vomiting (CINV).

The company stated that CINVANTI (HTX-019) is the first polysorbate 80-free, intravenous formulation of aprepitant for the prevention of CINV. Aprepitant belongs to a class of agents known as NK1 receptor antagonists, which are often used in combination with 5-HT3 receptor antagonists for the prevention of CINV.

Currently, the only injectable NK1 receptor antagonist approved in the US contains polysorbate 80, a surfactant, which may cause hypersensitivity reactions, infusion site reactions or other adverse reactions in some patients. Heron's formulation for CINVANTI does not contain polysorbate 80 and may have a lower incidence of certain types of adverse reactions than reported with the other commercially available injectable NK1 receptor antagonist.

This US NDA filing includes data demonstrating the bioequivalence of the company's CINVANTI to EMEND IV (fosaprepitant), supporting its efficacy for the prevention of both acute and delayed CINV with both moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC).

In conjunction with the trial, the results also showed CINVANTI was better tolerated than EMEND IV, with significantly fewer adverse events reported with CINVANTI, concluded the company.

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Publication:M2 Pharma
Date:Jan 13, 2017
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