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: |
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December 10, 2023 |
Time: |
|
3:30pm ET |
Location: |
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Room 4, Monitor 7 |
|
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About Eagle Pharmaceuticals, Inc. 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® (Japan), and BYFAVO® and BARHEMSYS® through
its wholly owned subsidiary Acacia Pharma Inc. Eagle’s oncology and
CNS/metabolic critical care pipeline includes product candidates
with the potential to address underserved therapeutic areas across
multiple disease states, and the company is focused on developing
medicines with the potential to become part of the personalized
medicine paradigm in cancer care. Additional information is
available on Eagle’s website at www.eagleus.com.
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,”
“remain,” “potential,” “prepare,” “expected,” “believe,” “plan,”
“near future,” “belief,” “guidance,” and similar expressions are
intended to identify forward-looking statements. These statements
include, but are not limited to, statements with respect to: the
potential benefits of Barhemsys, including its potential to present
a therapeutic option for patients with PONV; the ability of
Barhemsys and other products and product candidates to address
underserved therapeutic areas across multiple disease states; the
Company’s ability to develop medicines with the potential to become
part of the personalized medicine paradigm in cancer care; and the
anticipated unique J-code with CMS and the benefits associated
therewith. All 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: the timing and
ability of the Company’s reporting of financial and business
results, the Company’s ability to recruit and hire a new Chief
Executive Officer, the impacts of the post- COVID-19 environment
and geopolitical factors such as the conflicts between Russia and
Ukraine and Gaza and Israel; delay in or failure to obtain
regulatory approval of the Company's or its partners’ product
candidates and successful compliance with FDA, European Medicines
Agency and other governmental regulations applicable to product
approvals; changes in the regulatory environment; the uncertainties
and timing of the regulatory approval process; whether the Company
can successfully market and commercialize its product candidates;
the success of the Company's relationships with its partners; the
outcome of litigation involving any of its products or that may
have an impact on any of its products; the strength and
enforceability of the Company’s intellectual property rights or the
rights of third parties; competition from other pharmaceutical and
biotechnology companies and the potential for competition from
generic entrants into the market; unexpected safety or efficacy
data observed during clinical trials; clinical trial site
activation or enrollment rates that are lower than expected; the
risks inherent in drug development and in conducting clinical
trials; risks inherent in estimates or judgments relating to the
Company’s critical accounting policies, or any of the Company’s
estimates or projections, which may prove to be inaccurate; the
Company’s ability to maintain its listing on the Nasdaq Stock
Market; unanticipated factors in addition to the foregoing that may
impact the Company’s financial and business projections and
guidance and may cause the Company’s actual results and outcomes to
materially differ from its projections and guidance; and those
risks and uncertainties identified in the “Risk Factors” sections
of the Company's Annual Report on Form 10-K for the year ended
December 31, 2022, filed with the Securities and Exchange
Commission (the “SEC”) on March 23, 2023, the Company’s Quarterly
Reports on Form 10-Q for the quarter ended March 31, 2023, filed
with the SEC on May 9, 2023, and for the quarter ended June 30,
2023, filed with the SEC on August 8, 2023, and its other
subsequent filings with the SEC. Readers are cautioned not to place
undue reliance on these forward-looking statements. All
forward-looking statements contained in this press release speak
only as of the date on which they were made. Except to the extent
required by law, the Company undertakes no obligation to update
such statements to reflect events that occur or circumstances that
exist after the date on which they were made.
Indication and Important Safety Information for
Barhemsys® (amisulpride) Injection4
Indication
Barhemsys is a selective dopamine-2 (D2) and dopamine-3 (D3)
receptor antagonist indicated in adults for prevention of PONV
either alone or in combination with an antiemetic of a different
class and treatment of PONV in patients who have received
antiemetic prophylaxis with an agent of a
different class or have not received prophylaxis.
Important Safety Information
Contraindication
Barhemsys is contraindicated in patients with known
hypersensitivity to amisulpride.
QT Prolongation
Barhemsys causes dose- and concentration-dependent prolongation
of the QT interval. The recommended dosage is 10 mg as a
single intravenous (IV) dose infused over 1 to 2 minutes.
Avoid Barhemsys in patients with congenital long QT syndrome and
in patients taking droperidol.
Electrocardiogram (ECG) monitoring is recommended in patients
with pre-existing arrhythmias/cardiac conduction disorders,
electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia),
congestive heart failure, and in patients taking other medicinal
products (e.g., ondansetron) or with other medical
conditions known to prolong the QT interval.
Adverse Reactions
The most common adverse reaction, reported in ≥ 2% of
adult patients who received Barhemsys 10 mg (N=418) and
at a higher rate than placebo (N=416), in clinical trials for the
treatment of PONV was infusion site pain (6% vs. 4%).
Use in Specific Populations
Pregnancy
Available data with amisulpride use in pregnant women are
insufficient to establish a drug associated risk of major birth
defects, miscarriage or adverse maternal or fetal outcomes.
Lactation
Amisulpride is present in human milk. There are no reports
of adverse effects on the breastfed child and no information on the
effects of amisulpride on milk production.
Barhemsys may result in an increase in serum prolactin levels,
which may lead to a reversible increase in maternal milk
production. In a clinical trial, serum
prolactin concentrations in females (n=112) increased
from a mean of 10 ng/mL at baseline
to 32 ng/mL after Barhemsys treatment and from
10 ng/mL to 19 ng/mL in
males (n=61). No clinical consequences due to
elevated prolactin levels were reported.
To minimize exposure to a breastfed infant, lactating women may
consider interrupting breastfeeding and pumping and discarding
breast milk for 48 hours after receiving a dose of
Barhemsys.
Pediatric Use
Safety and effectiveness in pediatric patients have not been
established.
Geriatric Use
No overall differences in safety or effectiveness were observed
between these patients and younger patients, and other
reported clinical experience has not identified differences in
responses between the elderly and younger patients, but greater
sensitivity of some older individuals cannot be ruled out.
Drug Interactions
- Barhemsys causes dose- and
concentration-dependent QT prolongation. To avoid potential
additive effects, avoid use of Barhemsys in patients taking
droperidol.
- ECG monitoring is recommended in
patients taking other drugs known to prolong the QT interval (e.g.,
ondansetron).
- Reciprocal antagonism of effects
occurs between dopamine agonists
(e.g., levodopa) and Barhemsys. Avoid using levodopa with
Barhemsys.
Investor Relations for Eagle Pharmaceuticals,
Inc.: Lisa M. WilsonIn-Site Communications, Inc.T:
212-452-2793 E: lwilson@insitecony.com
Public Relations for Eagle Pharmaceuticals,
Inc.:Faith Pomeroy-WardT: 817-807-8044E:
faith@eagleus.com
________________________________
1 FDA labels for other recommended treatments do not include
treatment after failed prophylaxis.2 Habib AS, et al.
Anesthesiology. 2019; 130(2):203-212.3 Habib AS, et al. Curr Med
Res Opin. 2006; 22(6):1039-1099.4
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209510s005lbl.pdf
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/98de6d94-eb77-43a9-a6a2-f9261a4112b4
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