- FDA response highlights the importance of addressing suicidal
depression in adolescents age 9-17
- Alignment on initial Pediatric Study Plan (iPSP) is a gating
requirement for the upcoming filing of an NRX-100 New Drug
Application (NDA) for suicidal depression
- NRx remains on track to file the NDA for NRX-100 in Q4 2024
with anticipated PDUFA date in Q2 2025
RADNOR,
Pa., July 29, 2024 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the
"Company"), a clinical stage pharmaceutical company, today
announced a communication from the US Food and Drug Administration
(FDA) providing feedback and alignment on NRx's proposed initial
Pediatric Study Plan (iPSP) for NRX-100 (ketamine) in the treatment
of suicidal depression. Congress required the submission of an iPSP
as a precondition to filing a New Drug Application in the 2012 Food
and Drug Administration Safety and Innovation Act (FDASIA).[1]
Suicide is a growing crisis among adolescents in the United States. According to the US Centers
for Disease Control, 10% of high school students attempted suicide
in the past year and 22% of high school students reported having
seriously considered suicide. This percentage is highest among
females (30%), American Indians/Alaska Natives (27%), and lesbian,
gay, or bisexual teens (45%) (CDC, 2023). [2]
In support of its upcoming NDA filing, NRx will be submitting
existing data supporting the safety and efficacy of ketamine to
treat suicidal depression in adults. FDA has now documented its
recognition that suicide is a serious and growing public health
concern in adolescents as well. Based on the guidance received, NRx
and HOPE Therapeutics will commit to conducting a clinical trial of
NRX-100 in adolescents aged 9-17 with suicidal depression, but will
not be required to study the effects of NRX-100 in younger age
groups, following initial approval of NRX-100 in adults. Additional
neurotoxicity studies will be conducted in juvenile animal subjects
to support the safety of intravenous ketamine in this younger
population.
"Youth suicide has reached crisis proportions in the United States with a 62% increase over the
past two decades, disproportionately affecting minorities.[3] We
appreciate FDA's recognition of the urgent unmet medical need
related to suicidal depression in adolescents and look forward to
expanding the mission of NRx and HOPE Therapeutics to serve
America's youth in preventing needless deaths from suicidal
depression, said Prof. Jonathan
Javitt, Chairman of NRx Pharmaceuticals and Co-CEO of HOPE
Therapeutics."
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 recently announced plans to submit 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
care delivery company developing a best-in-class network of clinics
that currently offer ketamine 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. 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 https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/Pediatric-Study-Plans--Content-of-and-Process-for-Submitting-Initial-Pediatric-Study-Plans-and-Amended-Pediatric-Study-Plans.pdf
2
https://www.cdc.gov/healthyyouth/data/yrbs/pdf/YRBS_Data-Summary-Trends_Report2023_508.pdf
3
https://www.apa.org/monitor/2023/07/psychologists-preventing-teen-suicide
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