- Aiming to be the first FDA-approved medication to treat
suicidal depression
- Designed to help address the needs of the more than 13
million Americans who seriously consider suicide each year
(CDC)
- Completion of NDA filing expected in the first quarter of
2025
- Company to participate in 1x1 meetings in San Francisco during the Annual J.P. Morgan
Healthcare Conference on January 13-16,
2025, in San Francisco,
CA. To schedule meetings, please contact
jpm@astrpartners.com
WILMINGTON, Del., Dec. 30,
2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc.
(Nasdaq: NRXP) ("NRx", the "Company"), a clinical-stage
biopharmaceutical company, today announced the transmission of
first section of its New Drug Application (NDA) for NRX-100
(ketamine) for electronic filing with the U.S. Food & Drug
Administration (FDA). NRX-100 was initially granted Fast Track
Designation in 2017 for use in combination with NRX-101
(D-cycloserine/lurasidone) for treatment of suicidal bipolar
depression. The Company is now seeking to expand the indication to
include Suicidal Ideation in Major Depressive Disorder and other
forms of depression, based on data from NIH- and European
Government-funded trials that have been summarized on the Company's
website.
While assembly of the clinical data sections is being completed,
FDA has asked the Company to submit the 1800-page manufacturing
section (Module 3) of the NDA to enable immediate review prior to
submission of final efficacy data and other sections of the NDA
expected in the first quarter of 2025.
The NRx presentation of ketamine differs from the form of
ketamine used in anesthesia in that it contains no potentially
toxic preservatives and utilizes diversion-resistant packaging to
enhance the traceability of a medicine known to have abuse
potential.
Suicidal depression is considered a national crisis.
According to the CDC over 13 million Americans seriously consider
suicide each year and 3.8 million make a plan to do so.
"New treatment options are urgently needed for people at risk
with acute suicidal depression," said Dr. Jonathan Javitt, Chairman, CEO and Chief
Scientist. "Ketamine is already widely-used for the treatment
of suicidal depression on an off-label basis and is funded by the
Department of Defense and the Department of Veterans Affairs.
However, without FDA approval, its use is largely unreimbursed by
health insurers, with the exception of VA and DOD."
NRx thanks its shareholders, its clinical team, and the many
patients and caregivers who have participated in the clinical
trials.
NRX-100 (IV ketamine) for Suicidal Depression
Intravenous ketamine is widely accepted as a standard of care
for acute treatment of suicidal depression, in the absence of an
FDA-labeled product; the only treatment currently approved by the
FDA is electroconvulsive therapy (ECT). According to the CDC,
3.8 million Americans make a plan for suicide each year. This
represents a $3-5 billion market at
expected pricing. Based on the data in the trials referenced
above, the Company's regulatory counsel encouraged the Company to
file an NDA for suicidal depression for NRX-100.
About NRx Pharmaceuticals, Inc.
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
plans to file an NDA for Accelerated Approval
for NRX-101 in patients with bipolar depression and
suicidality or akathisia. NRX-101 additionally
has potential to act as a non-opioid treatment for
chronic pain, as well as a treatment for complicated
UTI.
NRx has begun submission of a New Drug Application for NRX-100
(IV ketamine) for 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 HOPE Therapeutics, Inc.
HOPE Therapeutics,
Inc. (www.hopetherapeutics.com) is a development stage
healthcare delivery company that intends to develop a best-in-class
network of precision psychiatry clinics to offer ketamine
transcranial magnetics stimulation (TMS) and
other lifesaving therapies to patients with suicidal depression and
related disorders, together with a digital therapeutic-enabled
platform designed to augment and preserve the clinical benefit
of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The
information contained herein includes forward-looking statements
within the meaning of Section 21E of the Securities Exchange Act of
1934, as amended, and Section 27A of the Securities Act of 1933, as
amended. Forward-looking statements generally include
statements that are predictive in nature and depend upon or refer
to future events or conditions, and include words such as "may,"
"will," "should," "would," "expect," "plan," "believe," "intend,"
"look forward," and other similar expressions among others. These
statements relate to future events or to the Company's future
financial performance, and involve known and unknown risks,
uncertainties and other factors that may cause the Company's actual
results to be materially different from any future results, levels
of activity, performance or achievements expressed or implied by
these forward-looking statements. You should not place undue
reliance on forward-looking statements since they involve known and
unknown risks, uncertainties and other factors which are, in some
cases, beyond the Company's control and which could, and likely
will, materially affect actual results, levels of activity,
performance or achievements. Any forward-looking statement reflects
the Company's current views with respect to future events and is
subject to these and other risks, uncertainties and assumptions
relating to the Company's operations, results of operations, growth
strategy, liquidity, Hope Therapeutic's ability to consummate the
acquisitions of providers for its national network, the Company's
ability to raise adequate capital to fund the Hope Therapeutics
acquisitions, and the Company's ability to spin-off Hope
Therapeutics. More detailed information about the Company and the
risk factors that may affect the realization of forward-looking
statements is set forth in the Company's most recent Annual Report
on Form 10-K and other filings with the Securities and Exchange
Commission. Investors and security holders are urged to read these
documents free of charge on the SEC's website
at http://www.sec.gov. Except as may
be required by applicable law, The Company assumes no obligation to
publicly update or revise these forward-looking statements for any
reason, or to update the reasons actual results could differ
materially from those anticipated in these forward-looking
statements, whether as a result of new information, future events
or otherwise.
For further information:
Matthew Duffy
Chief Business Officer,
NRx Pharmaceuticals
Co-Chief Executive Officer, HOPE
Therapeutics, Inc.
mduffy@nrxpharma.com
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SOURCE NRx Pharmaceuticals, Inc.
