- The benefits of ketamine are clear, but so are the
risks
- Ketamine has now demonstrated clear superiority to placebo
and non-inferiority to electroshock therapy in randomized trials
encompassing more than 1,000 patients
- NRx to file a New Drug Application for ketamine to treat
suicidal depression in 2024 in US and EU
RADNOR,
Pa., Jan. 2, 2024 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", (NRx),
a clinical-stage biopharmaceutical company today announced that it
has been selected to give the keynote address entitled "Ketamine
for Suicidal Depression: The Benefits are Clear, But So are the
Risks," at the upcoming Sachs Neuroscience Innovation Forum in
San Francisco, CA on January 7, 2024. The Company plans to file a New
Drug Application for Ketamine in 2024, both in the United States and the European Union in
partnership with the Fondation FundaMental of Paris, FR.
"When FDA first granted us Fast Track Designation to develop
ketamine as a life-saving drug for the treatment of suicidal
depression in 2017, evidence of efficacy was shown in only small
clinical trials," said Jonathan
Javitt, MD, MPH, Founder, Chairman, and Chief Scientist of
NRx Pharmaceuticals. "Ketamine's efficacy was so dramatic that
ketamine became a standard of care ahead of the large clinical
trials required for drug approval. Ketamine, as expected, now been
demonstrated to be dramatically superior to placebo in large
clinical trials. What could not be predicted is that ketamine has
been shown to be at least as good as (i.e. non-inferior) to
electroshock therapy (ECT), and in one trial demonstrated
superiority over ECT. The problem is that ketamine is sold only in
a 70 year old formulation designed for use in human and veterinary
anesthesia and cannot be used in the clinic setting without
quasi-legal compounding in a local pharmacy, a practice that FDA
has warned against. We have partnered with Nephron Pharmaceuticals
to develop a modern, single use, diversion- and tamper-resistant
formulation of ketamine. Moreover, we are partnering with
psychiatry leaders in the US and Europe to develop a Risk Evaluation and
Mitigation Strategy (REMS) program for ketamine that will include
training for providers in its safe and proper use."
NRx has advised its shareholders that it has incorporated HOPE
Therapeutics, Inc. to carry forward its drug development of
ketamine and will be awarding rights in HOPE to existing
shareholders together with new investors.
The Keynote presentation will be simulcast; information will be
available in the company's website, as well as a question and
answer session to be moderated by Bob "Sully" Sullivan of Biz
Talk.
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 is developing NRX-101, an FDA-designated
investigational Breakthrough Therapy for suicidal
treatment-resistant bipolar depression and chronic pain. NRx has
partnered with Alvogen Pharmaceuticals 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.
NRx has recently announced plans to submit a New Drug
Application for 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.
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.
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SOURCE NRx Pharmaceuticals, Inc.