- Ketamine, an NMDA blocker, was highly effective compared to
active comparator in rapidly reducing Suicidality
(p=0.0003)
- This study represents the second well-controlled trial NRx
has licensed supporting the use of IV Ketamine in suicidal
depression
- NRx plans to present the data from these two trials to FDA
in support of a New Drug Application to be filed in q1
2024
RADNOR,
Pa., Dec. 19, 2023 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the
"Company"), a clinical-stage biopharmaceutical company, today
announced that it has signed a License Data and Technical
Information Agreement with Columbia
University for rights to data from a randomized,
active-controlled trial of 80 patients hospitalized for Acute
Suicidality in Depression. This represents NRx's second
well-controlled trial demonstrating the efficacy of IV Ketamine in
this indication.
In this trial, Dr. Michael
Grunebaum and colleagues demonstrated a rapid and
statistically significant reduction in Suicidal Ideation (SSI) at
day 1 (p=0.0003) and in depression (P=0.0234), as measured by the
Profile of Mood States (POMS) among patients randomized to IV
Ketamine compared to those randomized to midazolam. This
trial was published in the American Journal of Psychiatry
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5880701/.
These data mirror the results recently reported by a French
consortium of hospitals who tested ketamine vs. placebo in acutely
suicidal patients. NRx established a similar data licensing
agreement in September, 2023 (NRx Ketamine Data Sharing,
France). The study was
published in the British Medical Journal
(BMJ 2022; 376 doi: https://doi.org/10.1136/bmj-2021-067194).
The company and its regulatory counsel believe these two
well-controlled trials meet the regulatory standard for a New Drug
Application (NDA) filing in early 2024. This filing will
include manufacturing and stability data from the Company's
partnership with Nephron Pharmaceuticals (West Columbia, SC).
"We at NRx are delighted to partner with the thought leaders at
Columbia University to help seek FDA
approval for this extraordinary public health need. Until now, the
only FDA-approved treatment for suicidal depression has been
electroshock therapy (ECT). Recent literature suggests that
ketamine may actually be superior to ECT in reducing suicidal
ideation, while certainly having a more benign side effect
profile," said Dr. Jonathan Javitt,
Founder and Chief Scientist of NRx Pharmaceuticals. "Although
ketamine is widely used off-label in the
United States and is considered standard of care by some
professionals, until it is labeled for treating depression and
suicidality it will be widely accessible only to those patients
able to pay out of pocket for their care and will continue to be
subject to various warnings about off label use of a controlled
substance."
Additional information about this initiative can be found on the
Company's website Ketamine FAQs.
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 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 announcement of NRx Pharmaceuticals, Inc. 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.
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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