- IND builds on previously-published, preliminary evidence of
efficacy
- Filing is supported by robust manufacturing, pre-clinical
and clinical data already reviewed by FDA for NRX-101 associated
with treatment of bipolar depression
RADNOR,
Pa., Aug. 30, 2023 /PRNewswire/ - NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the
"Company"), a clinical-stage biopharmaceutical company, today
announced submission an Investigational New Drug (IND) application
to the U.S. Food and Drug Administration (FDA) for the use of
NRX-101 to treat Chronic Pain. The IND application leverages
pioneering research on the use of D-cycloserine (a key ingredient
of NRX-101) in the treatment of chronic pain and the recent
licensure by NRx of a US Patent for the use of D-cycloserine in the
treatment of pain. Nonclinical and substantial clinical data are
already on file with FDA for NRX-101, which has already been
granted Breakthrough Therapy Designation for the treatment of
suicidal Bipolar Depression.
• IND builds on previously-published,
preliminary evidence of efficacy • Supported by robust
data
"One in five American adults suffers from chronic pain, a
condition for which there are few good solutions, once NSAIDs and
Tylenol-like drugs have been exhausted. There is a critical need
for non-addictive, non-neurotoxic, oral medicines, particularly
with the widespread recognition that opioids are not a viable
option for treatment," said Dr. Jonathan
Javitt, Founder, Chairman and Chief Scientist of NRx
Pharmaceuticals, Inc. "NRX-101 targets the NMDA receptor in
the brain, which has been demonstrated in extensive nonclinical and
early clinical studies to mediate the pain pathway."
Dr. Javitt continued "based on the preliminary evidence of
efficacy already demonstrated for the use of D-cycloserine in
Chronic Pain, we plan to seek Fast Track Designation, Priority
Review, and Breakthrough Therapy Designation for the use of NRX-101
to treat Chronic Pain. We have already completed the critical
manufacturing components required by FDA in connection with our
bipolar depression program and have sufficient quantities of our
investigational drug on hand to launch registrational studies in
2024, pending the results of the recently completed clinical trial
funded by the US Department of Defense."
NRX-101 in Chronic Pain
- Chronic pain is estimated to be a $72
billion industry today with the potential to grow to a
$120 billion industry by 2033.
- In June 2023, concurrent with
announcement of the Alvogen partnership, the Company announced an
expansion of its NRX-101 program to encompass treatment of chronic
pain as the next focus on NRX-101's development.
- The company recently announced the licensure of US Patent
8,653,120 related to the treatment of chronic pain with DCS and the
addition of Dr. Apkar Vania
Apkarian, Professor of Physiology, Anesthesia, Surgery, and
Neuroscience Institute, Northwestern
University Feinberg School of Medicine, to the NRx
Scientific Advisory Board. Dr. Apkarian is the inventor of the
patent and a global expert in pain research and has important
experience studying DCS in chronic pain.
- D-cycloserine (DCS) has been shown to modulate the Pain Pathway
at each point in the neural chain of pain: transmission at dorsal
horn of the spinal cord, pain perception in the thalamus ("paleo
brain"), and pain memory and processing between the paleo brain and
the cortex.
- In experimental models and clinical studies, NMDA antagonists
have demonstrated attenuation of pain and shown potential to reduce
opioid craving.
- DCS has demonstrated no potential for addiction, unlike
ketamine and other NMDA antagonists that bind to the "mu" opioid
receptor.
- DCS was evaluated in a pilot study at Northwestern University and showed efficacy at the
higher dose levels in the study (Schnitzer, 2016). DCS is currently
being examined in a confirmatory trial funded by the US Department
of Defense under the Congressionally Directed Medical Research
Program. The trial seeks to recruit approximately 200 participants
with chronic low back pain at Northwestern
University (clinicaltrials.gov
NCT03535688).1 Data collection is complete and
statistical results are expected in the coming months.
- Research conducted by NRx Pharmaceuticals demonstrated a 25
μg/ml dose at which D-cycloserine becomes an NMDA antagonist. The
400mg dose presented in the confirmatory trial at Northwestern University is at the lower end of the
threshold and suggests that the ability to increase the
D-cycloserine dose beyond 400mg, where lurasidone is used to
prevent CNS side effects in NRX-101.
About NRX-101
NRX-101, a fixed dose combination of D-cycloserine and
lurasidone, has been granted Fast Track Designation, Breakthrough
Therapy Designation, a Special Protocol Agreement, and a Biomarker
Letter of Support from the FDA for S-TRBD. Additionally, the
product is being developed in chronic pain and PTSD.
Up to 50% of individuals with bipolar disorder attempt suicide
over their lifetime, and estimates indicate that up to 20% may
succumb to suicide. The only FDA-approved treatment for patients
with treatment-resistant suicidal bipolar depression remains
electroconvulsive therapy.
Conventional antidepressants can increase the risk of suicide in
certain patients; hence their labels contain a warning to that
effect. NRX-101 is a patented, oral, fixed dose combination of
D-cycloserine and lurasidone, neither of which has shown addiction
potential in preclinical models. Based on the results of a Phase 2
proof-of-concept study, NRX-101 received Breakthrough Therapy
Designation from the FDA for the treatment of severe bipolar
depression in patients with ASIB after initial stabilization with
ketamine or other effective therapy.
NRX-101 is one of the first oral antidepressants currently in
late-stage clinical studies targeting the NMDA-receptor in the
brain, which represents potentially a key new mechanism to treat
depression with and without suicidality, as well as chronic pain,
PTSD and other indications.
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'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
is continuing to plan to enroll patients in an Israeli-based trial
of patients suffering from post-traumatic stress disorder with
depression and 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.
1 https://classic.clinicaltrials.gov/ct2/show/NCT03535688
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