109 0 Kommentare Eagle Pharmaceuticals to Present Additional Data from Phase III Trial Demonstrating Sustained Response of Amisulpride for the Rescue Treatment of Postoperative Nausea and Vomiting (PONV) at the Upcoming ASPAN 2024 National Conference in Orlando, Florida

-- Single dose, IV amisulpride (10 mg) results in sustained antiemetic effect with supratherapeutic plasma levels of drug being maintained for at least 24 hours in patients requiring PONV rescue versus placebo --

WOODCLIFF LAKE, N.J., April 15, 2024 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that data from the Company’s Phase III trial demonstrating the sustained response of amisulpride for the rescue treatment of postoperative nausea and vomiting (“PONV”) will be presented at the upcoming American Society of PeriAnesthesia Nurses (ASPAN) 2024 National Conference, which is being held April 14-18, 2024, in Orlando, Florida.

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 Mike Greenberg, MD, Vice President of Medical Affairs at Eagle Pharmaceuticals. “Based on what we believe to be encouraging results and corresponding PK data, we expect more healthcare providers to recognize the potential of PONV rescue treatment with amisulpride to enhance confidence in post-surgery and discharge outcomes.”

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