- The June 2024 meeting of the
American Society for Clinical Psychopharmacology (ASCP) focused
heavily on increasing use of intravenous ketamine and intranasal
S-ketamine as the emerging standard of care for treating severe
depression and suicidality
- Presenters from 3 open label studies at the ASCP suggested
that intravenous ketamine is at least equivalent and may have
advantages over intranasal S-ketamine
- NRx Pharmaceuticals has now reached the 9-month stability
point with its ketamine formulation (NRX-100) and has initiated 3
manufacturing lots for future drug release. Nonclinical safety for
short term use of NRX-100 has recently been published and submitted
to FDA
- FDA leadership, in public comments at ASCP, focused on the
need for nonclinical safety data for intravenous ketamine as a
condition of ketamine approval
- The short-term need for intravenous ketamine as an
already-approved, schedule 3 drug, is heightened by recent
regulatory decisions that may delay the path of potent, schedule 1
psychedelic drugs that may require more complicated clinical trial
designs.
RADNOR, Pa., June 10, 2024 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the
"Company"), a clinical-stage biopharmaceutical company, today
announced that the Company posted a new Shareholder Update Letter
on its website NRx Shareholder Update and further invites
interested parties to subscribe to their email alert service to
stay up to date on company's progress here: NRx Email Alerts .
(Note: not all updates will be included in a Press Release in the
future).
Today's update highlights potential implications of the
Company's recent activities at the annual meeting of the
American Society of Clinical Psychopharmacology. The
key points include:
- Intravenous and intranasal ketamine were highlighted as
emerging standards of care for severe depression and
suicidality
- Planned NDA filing for NRX-100, our preservative free IV
ketamine, for Suicidal Depression in 2024, is based on well
controlled trials against both placebo and active comparator. Fast
Track Designation was previously granted
- An independent FDA advisory panel recently voted against MDMA,
a potent, class I psychedelic, refocusing attention on
already-approved Schedule 3 drugs such as ketamine for treatment of
suicidal depression. The FDA panel and emerging guidance
highlights the complexity of clinical trials of DEA Schedule 1
hallucinogens that do not have already-approved human uses
- NRx anticipates that an important issue for longer term use of
ketamine in depression will be the current multidose vial
presentation that contains potentially toxic preservatives
previously acceptable for one time use but less suitable for
repeated use. NRX-100 is planned as a single-dose,
preservative-free medication.
Please subscribe to the Company's email for future
updates. NRX Email Alerts Not all of these will be the
subject of a Press Release in the future.
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 has partnered with Alvogen and Lotus 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, 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 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
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.
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SOURCE NRx Pharmaceuticals, Inc.
