- No current FDA-approved formulation of ketamine for
treatment of depression and suicidality
- Partners are developing a proprietary, tamper and
diversion-resistant formulation and packaging
- Finished drug with two-year shelf stability targeted for
November 2024, pending FDA
approval
- Partners aim to submit New Drug Application by March 1, 2024
RADNOR,
Pa. and WEST COLUMBIA,
S.C., Nov. 6, 2023 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", (NRx),
a clinical-stage biopharmaceutical company and Nephron
Pharmaceuticals, Inc. (Nephron), a leading manufacturer of sterile
injectable drugs today announced the signing of a development and
manufacturing agreement to manufacture a presentation of ketamine
suitable for treating suicidal depression, an urgent public health
need. Recent CDC data suggest that more than 3 million Americans
have active thoughts of suicide and more than 50,000 die from
suicide each year.
![(PRNewsfoto/NRx Pharmaceuticals) (PRNewsfoto/NRx Pharmaceuticals)](https://mma.prnewswire.com/media/1734122/NRX_Logo_Logo.jpg)
Ketamine has increasingly been recognized as valuable for rapid
reduction of suicidal thoughts as part of a comprehensive program
of care and its use in depression has been endorsed as standard of
care by both the US Department of Defense and the Veterans
Administration. However, no manufactured presentation of ketamine
with been submitted to or approved by the US FDA for this purpose
and caregivers rely on ad hoc compounding of ketamine, a practice
that has been the topic of recent FDA warnings.
Submission of a New Drug Application for ketamine depends upon
both the availability of data demonstrating safety and efficacy
from well-controlled trials and upon the submission of data for a
manufactured product demonstrating adherence to Good Manufacturing
Practices and long term stability, among other requirements. These
requirements are intended to be met via the NRx/Nephron
partnership.
"We at NRx are excited to partner with Lou Kennedy and her team at Nephron and to avail
ourselves of Nephron's decades of manufacturing excellence in
developing a lifesaving product that has the potential to be
available for patients by the end of 2024.," said Dr. Jonathan Javitt of Founder and Chief Scientist
of NRx Pharmaceuticals. "We aim to combine Nephron's history of
producing highly-regarded FDA-inspected products with data from
well-controlled clinical trials in seeking approval from FDA and
regulators around the world."
"There are few efforts as important as playing a role - through
research and development - in tackling the nation's mental health
crisis," said Lou Kennedy CEO and owner of Nephron Pharmaceuticals.
"To this end, we are honored to partner with NRx Pharmaceuticals in
a groundbreaking endeavor. Together, we are advancing the
production of single-dose, intravenous Ketamine, which could be a
crucial breakthrough for the treatment of depression. Not only are
we addressing an immediate demand, but we are also laying the
foundation for a potential New Drug Application, signifying a
significant leap forward in the improvement of mental health
outcomes for patients."
About NRx Pharmaceutical
NRx Pharmaceuticals is a
clinical-stage biopharmaceutical company developing therapeutics
based on its NMDA platform for the treatment of central nervous
system disorders, specifically suicidal bipolar depression, chronic
pain and PTSD. The Company is developing NRX-101, an FDA-designated
investigational Breakthrough Therapy for suicidal
treatment-resistant bipolar depression and chronic pain. NRx has
partnered with Alvogen Pharmaceuticals around the development and
marketing of NRX-101 for the treatment of suicidal bipolar
depression. NRX-101 additionally has potential to act as a
non-opioid treatment for chronic pain.
NRx has recently announced plans to submit a New Drug
Application for ketamine in the treatment of suicidal depression,
based on results of well-controlled clinical trials conducted under
the auspices of the US National Institutes of Health and newly
obtained data from French health authorities, licensed under a data
sharing agreement. NRx was awarded Fast Track Designation for
development of ketamine (NRX-100) by the US FDA as part of a
protocol to treat patients with acute suicidality.
About Nephron Pharmaceuticals
A West Columbia, S.C.-based company, Nephron
develops and produces safe, affordable sterile pharmaceutical
products in a state of the art GMP-compliant manufacturing
facility. The company also operates an industry-leading
503B Outsourcing Facility division
which produces pre-filled sterile syringes, luer-lock vials, IV
bottles and IV bags for hospitals across America, in an effort to
alleviate drug shortage needs. For more information, please
visit www.nephronpharm.com.
Cautionary Note Regarding Forward-Looking
Statements
This press release includes "forward-looking
statements" within the meaning of the "safe harbor" provisions of
the U.S. Private Securities Litigation Reform Act of 1995, which
may include, but are not limited to, statements regarding our
financial outlook, product development, business prospects, and
market and industry trends and conditions, as well as the Company's
strategies, plans, objectives, and goals. These forward-looking
statements are based on current beliefs, expectations, estimates,
forecasts, and projections of, as well as assumptions made by, and
information currently available to, the Company's management.
Actual results could differ materially from those contemplated by
the forward-looking statements. A discussion of these and other
factors, including risks and uncertainties with respect to the
Company, is set forth in the Company's filings with the Securities
and Exchange Commission, including its Annual Report on Form 10-K,
as may be supplemented, or amended by the Company's Quarterly
Reports on Form 10-Q. Given these risks, uncertainties, and
factors, you are cautioned not to place undue reliance on such
forward-looking statements, which are qualified in their entirety
by these cautionary statements.
The Company assumes no obligation to revise any forward-looking
statement, whether as a result of new information, future events or
otherwise. Accordingly, you should not place reliance on any
forward-looking statement, and all forward-looking statements are
herein qualified by reference to the cautionary statements set
forth above.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-and-nephron-pharmaceuticals-announce-joint-agreement-to-develop-intravenous-ketamine-to-treat-suicidal-depression-301978148.html
SOURCE NRx Pharmaceuticals, Inc.