EAGLE PHARMACEUTICALS, INC. The data being presented relate to a prespecified pharmacokinetic ('PK') subset of patients from a Phase III, randomized, multicenter, double-blind, placebo-controlled, parallel-group study in adult surgical patients with moderate to high risk of PONV who failed antiemetic prophylaxis. The purpose of the analysis was to evaluate the plasma concentrations of a single dose of IV amisulpride 10 mg for rescue treatment of PONV.
The PK data from a subset of patients in this Phase III trial demonstrate that supratherapeutic amisulpride plasma levels can be maintained for at least 24 hours after a single 10 mg dose, which may resultin clinically meaningful, sustained antiemetic effect for PONV rescue when compared to the placebo arm.
'The PK data from this subset of patients in this Phase 3 study demonstrate that a single treatment with amisulpride is capable of delivering a sustained response, which we believe is particularly useful in the rescue setting where patients have already failed antiemetic prophylaxis therapy,' stated
Details of the poster presentation are as follows
Abstract Title: Documented Sustained Response of Intravenous Amisulpride for Rescue Treatment of Postoperative Nausea and Vomiting: Results from a Phase III Trial
Date:
Presenter: Dr.
About
Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients' lives. Eagle's commercialized products include PEMFEXY, RYANODEX, BENDEKA, BELRAPZO, TREAKISYM (
Forward-Looking Statements
This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other securities law. Forward-looking statements are statements that are not historical facts. Words and phrases such as 'anticipated,' 'forward,' 'will,' 'would,' 'could,' 'may,' 'intend,' 'remain,' 'potential,' 'prepare,' 'expect,' 'believe,' 'plan,' 'seek,' 'continue,' 'estimate,' and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, the potential benefits and usefulness of amisulpride/Barhemsys, including its potential to present a therapeutic option for patients with PONV; the ability of amisulpride/Barhemsys to provide a sustained response, including in rescue settings where patients have already failed antiemetic prophylaxis therapy; the potential for more healthcare providers to recognize the potential of PONV rescue treatment with amisulpride to enhance confidence in post-surgery and discharge outcomes; the potential of product candidates to address underserved therapeutic areas across multiple disease states, including with the potential to become part of the personalized medicine paradigm in postoperative care. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the Company's control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Such risks and uncertainties include, but are not limited to: trial results may not be indicative of future trial results or commercial results; the completion of the review and preparation of the Company's financial statements and internal control over financial reporting and disclosure controls and procedures and the timing thereof; the discovery of additional information; further delays in the Company's financial reporting, including as a result of unanticipated factors; the Company's ability to comply with its obligations under its credit agreement; the possibility that the Company will be unable to regain compliance with, or thereafter continue to comply with, the Nasdaq Listing Rules, or experience violations of additional Nasdaq Listing Rules; the possibility that the Nasdaq may delist the Company's securities; the Company's ability to remediate material weaknesses in its internal control over financial reporting; the Company's ability to recruit and hire a new Chief Executive Officer and new Chief Financial Officer; the ability of the Company to realize the anticipated benefits of its plan designed to improve operational efficiencies and realign its sales and marketing expenditures and the potential impacts thereof; the impacts of the post- COVID-19 environment and geopolitical factors such as the conflicts between
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