- FDA-compliant manufacture of intravenous Ketamine is a
required component of a New Drug Application
- Intravenous Ketamine has become widely used for treating
depression and suicidality but has never been presented to FDA for
approval
- Potential to file New Drug Application for Ketamine in 2024
based on existing clinical data and newly-developed, modern
commercial manufacturing protocols
- Further information is anticipated to be released in an
upcoming 8K securities
filing
RADNOR,
Pa., Oct. 31, 2023 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the
"Company"), a clinical-stage biopharmaceutical company today
announced the signing of a development contract to manufacture a
presentation of ketamine suitable for intravenous administration
under current FDA manufacturing regulations. Existing supplies of
Ketamine are not labeled for treatment of depression and
suicidality and often do not conform to modern manufacturing
requirements for single-dose injectable medications. NRx and its
manufacturing partner plan to release further information in an
upcoming 8K filing.
As intravenous Ketamine becomes more widely used to treat
depression and suicidality, the supply of Ketamine – which today is
approved only for use as an anesthetic – becomes increasingly
tenuous. Moreover, suppliers of Ketamine are increasingly
challenged by FDA warnings to patients and healthcare providers
about potential risks associated with compounded Ketamine
products.1 Compounded products are distributed under
state pharmacy laws by compounding pharmacies and may not comply
with various aspects of the Food, Drug, and Cosmetics Act.
"We at NRx are excited to have identified a strong manufacturing
partner for the development of what we anticipate will be a
lifesaving product that has the potential to be available for
patients by the end of 2024. We and our partner look forward to
sharing further information as the manufacturing, regulatory, and
business plans are finalized," said Stephen
Willard, JD, CEO of NRx Pharmaceuticals.
About NRx Pharmaceutical
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's lead program NRX-101, an oral,
fixed-dose combination of D-cycloserine and lurasidone, targets the
brain's N-methyl-D-aspartate (NMDA) receptor and is being
investigated in a Phase 2b/3 clinical
trial for suicidal treatment-resistant bipolar depression (S-TRBD),
which includes patients with both acute and sub-acute suicidality,
an indication for which the only approved treatment is electroshock
therapy. The Company has partnered with Alvogen Pharmaceuticals,
who owns the worldwide rights to NRX-101 for treatment of S-TRBD,
to help bring NRX-101 to a global population of patients with unmet
medical need. NRx Pharmaceuticals is currently exploring NRX-101's
potential to act as a non-opioid chronic pain treatment option and
has recently announced a renewed focus on the use of intravenous
ketamine for treatment of acute suicidality.
Cautionary Note Regarding Forward-Looking Statements
This press release includes "forward-looking statements" within
the meaning of the "safe harbor" provisions of the U.S. Private
Securities Litigation Reform Act of 1995, which may include, but
are not limited to, statements regarding our financial outlook,
product development, business prospects, and market and industry
trends and conditions, as well as the Company's strategies, plans,
objectives, and goals. These forward-looking statements are based
on current beliefs, expectations, estimates, forecasts, and
projections of, as well as assumptions made by, and information
currently available to, the Company's management. Actual results
could differ materially from those contemplated by the
forward-looking statements. A discussion of these and other
factors, including risks and uncertainties with respect to the
Company, is set forth in the Company's filings with the Securities
and Exchange Commission, including its Annual Report on Form 10-K,
as may be supplemented, or amended by the Company's Quarterly
Reports on Form 10-Q. Given these risks, uncertainties, and
factors, you are cautioned not to place undue reliance on such
forward-looking statements, which are qualified in their entirety
by these cautionary statements.
The Company assumes no obligation to revise any forward-looking
statement, whether as a result of new information, future events or
otherwise. Accordingly, you should not place reliance on any
forward-looking statement, and all forward-looking statements are
herein qualified by reference to the cautionary statements set
forth above.
1
https://www.fda.gov/drugs/human-drug-compounding/fda-warns-patients-and-health-care-providers-about-potential-risks-associated-compounded-ketamine
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SOURCE NRx Pharma