- New Drug Application (NDA) for Accelerated Approval planned
for NRX-101 in people with bipolar depression and akathisia in
2024, based on two positive trials 1 2 and Breakthrough
Therapy Designation. Potential revenue in 2025
- NDA for NRX-100 (IV ketamine) in suicidal depression in
advanced preparation for submission in 2024; based on four positive
trials 3 4 5 6 and Fast Track Designation. Potential
revenue in 2025
- Gaining these approvals has the potential to yield more than
$150 in revenue per NRXP share in the
near term, at current share count
- Planning for HOPE Therapeutics share distribution
progresses; audit nearing completion – critical step towards a
public listing
RADNOR,
Pa., June 28, 2024 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the
"Company"), a clinical-stage biopharmaceutical company, today
announced that advice from regulatory counsel, which includes
former senior officials from the Food and Drug Administration,
supports filing two New Drug Applications (NDAs) in 2024: an
application for Accelerated Approval for NRX-101 to treat bipolar
depression in patients with akathisia and an application for
approval of NRX-100 (IV ketamine) for treatment of suicidal
depression.
While efficacy and safety data are now in hand, filing of the
above applications is dependent upon completion of 12-month
stability data in manufactured lots as required by FDA
regulations.
As disclosed in an 8K filing, NRx
will be filing the NRX-101 application without a commercial
partner. The addressable market for the accelerated approval
indication is such that a compact and efficient salesforce can be
constructed by a small company, such as NRx, and current executives
at NRx have previously held primary responsibility for launch of
similar-sized pharmaceutical assets.
NRx continues work to enable the distribution of shares in Hope
Therapeutics. This distribution is dependent upon completion
of a public audit and successful review of an SEC Form 10.
"The NRx team has worked diligently since the end of the COVID
pandemic to achieve these milestones for our shareholders and most
importantly the patients we have always sought to help," said Dr.
Jonathan Javitt, Chairman and Chief
Scientist of NRx. "Given the near-term market opportunity
represented by an accelerated approval process, NRx anticipates a
higher potential return to NRx investors associated with an NRx-led
initiative than that which would likely be achieved with a large
commercial partner."
NRX-101 for Bipolar Depression
NRX-101 is the Company's patented (Composition of Matter), oral
combination of the NMDA antagonist D-cycloserine and lurasidone for
bipolar depression. Data from two active control clinical
trials vs. the standard of care, lurasidone, have shown comparable
antidepressant efficacy with clinically important reductions in
suicidality and/or akathisia. To the Company's knowledge, no
other oral agent has demonstrated such a valuable profile.
Up to 15% of people treated with drugs in lurasidone's class
develop akathisia7; this would constitute an estimated
$3.7 billion initial market for
NRX-101, with no approved medicines for akathisia. This is a
population the Company can readily address without a large
commercial partner, given the relatively small number of
psychiatrists who treat high-risk patients. The broad bipolar
market constitutes 7 million people and an opportunity greater than
$20 billion per year. With a
best-in-class product profile, the Company projects NRX-101 sales
in excess of $2
billion.
NRX-101 was awarded Breakthrough Therapy Designation, Fast Track
Designation, a Biomarker Letter of Support, and a Special Protocol
Agreement by the FDA for treatment of suicidal bipolar
depression.
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 FDA
is electroconvulsive therapy (ECT).
According to the CDC, 3.5 million Americans make a plan for
suicide each year.8 This represents a $3-5 billion market at expected pricing.
Based on the data in the trials referenced above, the Company's
regulatory counsel has encouraged the Company to file an NDA for
suicidal depression for NRX-100. This application has been in
development and awaits 12-month stability data for filing, which is
expected in 2024.
About NRx Pharmaceuticals
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-101 additionally has potential to act as a
non-opioid treatment for chronic pain, as well as a treatment for
complicated UTI.
NRx has recently announced plans to submit a New Drug
Application for NRX-100 (IV 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 agreements. 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
Specialty Pharmaceutical Company, wholly-owned by NRX
Pharmaceuticals focused on development and marketing of an
FDA-approved form of intravenous ketamine for the treatment of
acute suicidality and depression 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. These statements include, among others,
statements regarding the proposed public offering and the timing
and the use of the proceeds from the offering. 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 and liquidity. 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.
1 Nierenberg A, Lavin P, Javitt DC, et. al.
NRX-101 vs lurasidone for the maintenance of initial stabilization
after ketamine in patients with severe bipolar depression with
acute suicidal ideation and behavior; a randomized prospective
phase 2 trial. Int J Bipolar Dis 2023;11:28-38, STABIL-B
2 Nierenberg, et. al., A Randomized, Double-Blind
Controlled Comparison of NRX-101 (D-cycloserine/lurasidone) to
Lurasidone for Adults with Bipolar Depression and Subacute Suicidal
Ideation or Behavior. Am Soc Clin Psych Annual Meeting 2024.
ASCP Poster
3 Fava, M et. al.,
Double-blind, placebo-controlled, dose-ranging trial of intravenous
ketamine as adjunctive therapy in treatment-resistant depression
(TRD) Mol Psychiatry. 2020; 25(7): 1592–1603.
4 Grunebaum, et. al., Ketamine for Rapid Reduction of
Suicidal Thoughts. Am J Psychiatry. 2018 Apr
1: 175(4): 327-335
5 Abbar, et. al. Ketamine for Acute Treatment of Severe
Suicidal Ideation, BMJ 2022; 376
6 Anand, et. al, Ketamine is non-inferior to ECT for
non-psychotic treatment resistant depression. NEJM 2023
388(25):2315-2325
7 Chow, C, et. Al., Akathisia and Newer
Second-Generation Antipsychotic Drugs: A Review of Current
Evidence
Pharmacotherapy 2020;40(6):565–574
8 CDC Suicide Data.
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SOURCE NRx Pharmaceuticals, Inc.