- Formulation based on prior patents by NRx founder
- Achieved pH neutral formulation of ketamine, potentially
enabling both intravenous (IV) and subcutaneous (SQ)
administration
- Company expects Composition of Matter patent protection
- Company previously executed joint development agreement with US
manufacturer of insulin pumps
RADNOR,
Pa., April 15, 2024 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", "NRx",
the "Company"), a clinical-stage biopharmaceutical company, today
announced that the Company has developed a novel, proprietary
formulation of IV Ketamine for use as HTX-100. This new
formulation has the key advantage of achieving neutral pH, in
contrast to the acidic pH of generic formulations of ketamine.
Acidic substances are tolerated when diluted for intravenous use,
but cause pain and may cause skin ulcers if administered
subcutaneously. This patentable invention may enable the
administration of ketamine in insulin pump-like devices in the
clinic setting, eliminating the requirement for intravenous
infusion personnel. NeuroRx, Inc. previously executed a joint
development agreement with a manufacturer of insulin pumps but has
been awaiting a suitable, pH neutral formulation of ketamine.
With this proprietary formulation, developed with our partner
Nephron Pharmaceuticals, a leading sterile products manufacturer,
NRx is expected to generate one or more patents, such as
composition of matter or formulation.
HTX-100 is expected to be marketed by HOPE Therapeutics, Inc., a
wholly owned subsidiary of NRx.
"The current formulation of IV Ketamine was developed for
battlefield use in the 1960s and has remained relatively static
since then. With our new formulation, and Nephron's state of
the art manufacturing expertise, we are pleased to be approaching
the market with an improved formulation ready for use in modern
medicine," said Dr. Jonathan Javitt, Founder, Chairman and
Chief Scientist of NRx Pharmaceuticals. "Development of a
pH-neutral, subcutaneous form of ketamine administration enables a
significantly less complex route of administration in the
outpatient setting. Moreover, advances in insulin pump technology
create the potential to monitor the brain wave activity and other
physiologic parameters associated with ketamine administration and
modulate ketamine therapy based on the patient's individual
physiologic response."
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 HTX-100 (IV ketamine), through Hope Therapeutics,
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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-nasdaqnrxp-announces-development-of-new-proprietary-formulation-of-htx-100-iv-ketamine-302116345.html
SOURCE NRx Pharmaceuticals, Inc.