Eagle Pharmaceuticals To Present Abstract On Post-Hoc Analysis Of Amisulpride At The 77th PGA In New York City

Author: Benzinga Newsdesk | December 06, 2023 05:29pm

-- BARHEMSYS® (amisulpride) Injection is the first and only antiemetic approved by the U.S. Food and Drug Administration ("FDA") for rescue treatment of postoperative nausea and vomiting ("PONV") despite prophylaxis1 and is also approved for the treatment of PONV in patients who have not received prophylaxis and for the prevention of PONV --

-- In patients who experience PONV, the incidence of nausea is substantially greater than the incidence of vomiting2,3 --

-- This post-hoc analysis of pivotal trials demonstrates that Barhemsys provides statistically significant (p=0.006) nausea relief in patients with established PONV --

-- A single 10 mg dose of intravenous amisulpride significantly reduced patients' nausea across multiple measures, including significant nausea, use of rescue medication, and evolution of nausea over time, and the adverse event profile was comparable between the placebo and 10 mg amisulpride arms –

-- Unique J-code for Barhemsys (J-0184) from CMS effective on January 1, 2024 --

 

WOODCLIFF LAKE, N.J., Dec. 06, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced that its abstract, a post-hoc analysis of two multicenter, placebo-controlled, Phase III studies evaluating amisulpride (a selective dopamine D2/D3 antagonist) as an antiemetic in patients with established postoperative nausea and vomiting, has been selected for a poster presentation at the 77th PGA (PostGraduate Assembly in Anesthesiology), being held December 8-11, 2023, in New York City. The conference is sponsored by the New York State Society of Anesthesiologists and is a global platform for presenting anesthesia's latest science and technologies.

"PONV contributes to prolonged post-anesthesia care unit and hospital stays and is distressing to patients and healthcare providers," stated Mike Greenberg, MD, Vice President of Medical Affairs at Eagle Pharmaceuticals. "In patients who experience PONV, nausea occurs much more frequently than vomiting. This analysis details pooled data on nausea-related outcomes from two Phase III trials. We are pleased to share that the proportion of patients with PONV experiencing substantial nausea in these studies was statistically significantly lower in the amisulpride 10 mg group than in the placebo group. We believe Barhemsys presents an opportunity for a much-needed therapeutic option for these patients," concluded Dr. Greenberg.

Details of the poster presentation are as follows:

Abstract Title: Amisulpride Provides Significant Nausea Reduction in Patients with Established Postoperative Nausea and Vomiting: Pooled Results from Two Phase III Trials

 

Date:	December 10, 2023
Time:	3:30pm ET
Location:	Room 4, Monitor 7

Posted In: EGRX