Xeris Pharmaceuticals Granted Fast Track Designation by the FDA for Its Novel Concentrated Diazepam Formulation (XP-0863) For...
October 20 2020 - 04:05PM
Business Wire
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty
pharmaceutical company leveraging its novel technology platforms to
develop and commercialize ready-to-use injectable and infusible
drug formulations, today announced it was granted Fast Track
designation by the Food and Drug Administration (FDA) for the
investigation of XP-0863 (diazepam non-aqueous injection) for the
treatment of acute repetitive seizures. Xeris’ XP-0863 was
previously granted orphan designations both for the treatment of
acute repetitive seizures and for the treatment of Dravet
Syndrome.
"The FDA's Fast Track designation highlights the clear unmet
need in treating acute repetitive seizures with the preparations of
diazepam available today and highlights our opportunity to
dramatically improve care through the introduction of a
ready-to-use injection formulation," said Paul R. Edick, Xeris’
Chairman and Chief Executive Officer. "We are working to identify
the right development and commercialization partner who can
accelerate our efforts to evaluate and deliver this simple format
that could make all the difference in an urgent seizure
setting."
As previously announced, complete results of the Phase 1b study
were shared with the US FDA in an End-of-Phase 1 interaction. The
FDA provided feedback that Xeris’ drug development program for
XP-0863 could advance directly into a Phase 3 registration study in
both pediatric and adult patients with epilepsy.
About Diazepam
Diazepam is in a class of medications called benzodiazepines. It
works by calming abnormal overactivity in the brain. Diazepam is
used in emergency situations to stop cluster seizures (episodes of
increased seizure activity) in people who are already taking
medications to control their seizures. Diazepam is only recommended
for short-term treatment of seizure attacks. Uncontrolled seizures
can turn into serious (possibly fatal) seizures that do not stop
(status epilepticus).
About Acute Repetitive Seizures
There are over 2.7 million people with epilepsy in the United
States with approximately 200,000 new patients diagnosed each year.
It is estimated that between 30% and 40% of these patients are
uncontrolled on oral therapy and are at risk for acute breakthrough
seizures. Acute repetitive or cluster seizures may occur over a
number of hours or days and can include any seizure type. Studies
have shown that prolonged or repetitive seizures can cause
neurological damage and dramatically increase the risk of changes
in neuropsychological function or even death.
About Xeris Pharmaceuticals, Inc.
Xeris (Nasdaq: XERS) is a specialty pharmaceutical company
delivering innovative solutions to simplify the experience of
administering important therapies that people rely on every day
around the world.
With a novel technology platform that enables ready-to-use,
room-temperature stable formulations of injectable and infusible
therapies, the company is advancing a portfolio of solutions in
various therapeutic categories, including its first commercial
product, Gvoke®. Its proprietary XeriSol™ and XeriJect™ formulation
technologies have the potential to offer distinct advantages over
conventional product formulations, including eliminating the need
for reconstitution, enabling long-term, room-temperature stability,
significantly reducing injection volume, and eliminating the
requirement for intravenous (IV) infusion. With Xeris’ technology,
new product formulations are designed to be easier to use by
patients, caregivers, and health practitioners and help reduce
costs for payers and the healthcare system.
Xeris is headquartered in Chicago, IL. For more information,
visit www.xerispharma.com, or follow us on Twitter, LinkedIn or
Instagram.
Forward-Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Xeris Pharmaceuticals, Inc., including
statements regarding the market and therapeutic potential of its
product candidates, expectations regarding clinical data or results
from planned clinical trials, the timing or likelihood of
identifying a potential development and commercialization partner,
the timing or likelihood of regulatory approval and
commercialization of its product candidates, the timing or
likelihood of expansion into additional markets, the potential
utility of its formulation platforms and other statements
containing the words "will," "would," "continue," and similar
expressions, constitute forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by such
forward-looking statements as a result of various important
factors, including, without limitation, the regulatory approval of
its product candidates, its ability to market and sell its
products, if approved, its reliance on a single source supplier for
Gvoke HypoPen™ , the impact of COVID-19 on its business operations,
and other factors discussed in the "Risk Factors" section of the
most recently filed Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission, as well as discussions of
potential risks, uncertainties, and other important factors in
Xeris’ subsequent filings with the Securities and Exchange
Commission. Any forward-looking statements contained in this press
release speak only as of the date hereof, and Xeris expressly
disclaims any obligation to update any forward-looking statements,
whether as a result of new information, future events or
otherwise.
The Company intends to use the investor relations portion of its
website as a means of disclosing material non-public information
and for complying with disclosure obligations under Regulation
FD.
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Investor Contact Allison Wey Senior Vice President,
Investor Relations and Corporate Communications
awey@xerispharma.com 312-736-1237
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