Trending...
- AdvisorVault Adds Social Media Archiving to its Consolidated D3P Service
- City of Spokane Launches New Webpage, Notice Document to Connect Residents with Eviction Prevention Resources
- Ecuador Freedom Launches First Scheduled Motorcycle Tour of Northern Peru's Lost Kingdoms
$NRXP: Completion of NDA Filing Expected in First Quarter of 2025
MIAMI - Washingtoner -- Developing NRX-101, an FDA-Designated Investigational Breakthrough Therapy for Suicidal Treatment-Resistant Bipolar Depression and Chronic Pain.
Aiming to be the First FDA-Approved Medication to Treat Suicidal Depression
Designed to Help Address the Needs of Over 13 Million Americans who Seriously Consider Suicide Each Year (CDC).
Plans to Participate in J.P. Morgan Healthcare Conference on January 13-16, 2025, in San Francisco, CA.
Publication of Paper Entitled "Quality Assurance of Depression Ratings in Psychiatric Clinical Trials."
Featured on Psychiatrist.com: "How NRx Could Upend the Fight Against Depression and Suicide."
NRx Pharmaceuticals, Inc. (Stock Symbol: NRXP) 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. NRXP is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain
NRXP 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, as well as a treatment for complicated UTI.
NRXP is working on a New Drug Application for NRX-100 (IV 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. NRXP 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.
Intravenous ketamine is widely accepted as a standard of care for acute treatment of suicidal depression, in the absence of an FDA-labeled product; the only treatment currently approved by the FDA is electroconvulsive therapy (ECT). According to the CDC, 3.8 million Americans make a plan for suicide each year. This represents a $3-5 billion market at expected pricing. Based on the data in the trials referenced above, the Company's regulatory counsel encouraged the Company to file an NDA for suicidal depression for NRX-100.
More on Washingtoner
Initial Section of U.S. New Drug Application to the FDA for NRX-100 (IV Ketamine) for the Treatment of Suicidal Depression
On December 30th NRXP announced the transmission of first section of its New Drug Application (NDA) for NRX-100 (ketamine) for electronic filing with the U.S. Food & Drug Administration (FDA). NRX-100 was initially granted Fast Track Designation in 2017 for use in combination with NRX-101 (D-cycloserine/lurasidone) for treatment of suicidal bipolar depression. The Company is now seeking to expand the indication to include Suicidal Ideation in Major Depressive Disorder and other forms of depression, based on data from NIH- and European Government-funded trials that have been summarized on the NRXP website.
While assembly of the clinical data sections is being completed, FDA has asked the Company to submit the 1800-page manufacturing section (Module 3) of the NDA to enable immediate review prior to submission of final efficacy data and other sections of the NDA expected in the first quarter of 2025.
The NRx presentation of ketamine differs from the form of ketamine used in anesthesia in that it contains no potentially toxic preservatives and utilizes diversion-resistant packaging to enhance the traceability of a medicine known to have abuse potential.
Publication of Paper Entitled "Quality Assurance of Depression Ratings in Psychiatric Clinical Trials"
On November 25th NRXP announced the publication of a paper by Sapko, et. al. in the peer-reviewed American Journal of Clinical Psychopharmacology. The paper, entitled "Quality Assurance of Depression Ratings in Psychiatric Clinical Trials,"1 reported on the impact of a comprehensive program developed by NRx Pharmaceuticals to enhance reliability in psychometric ratings that are key to drug approval. Registration trials of drugs for depression and related conditions frequently fail because of unexpected statistical variability across study sites. NRx developed a methodology for training and monitoring the performance of the study site raters, whose measurements are key to the success or failure of all clinical trials of antidepressant drugs. This approach resulted in an unprecedented level of agreement (3 points or better on a 60 point scale) compared to prior industry practices.
More on Washingtoner
In the NRX-101 study, trial concordance, as defined by no more than 3 points of disagreement between site raters and central raters, was seen in 94.5% of ratings, where standard industry practice was to accept substantially higher variance (i.e. up to 6 points of disagreement) between study site raters and central raters.2 Accepting higher variance entails recruiting many more participants to achieve statistical significance with substantially higher study costs and risks of failure. NRXP will be using this improved methodology in future drug development, and clinical trials conducted within its network of HOPE clinics.
NRx Pharmaceuticals, Inc. Featured on Psychiatrist.com: "How NRx Could Upend the Fight Against Depression and Suicide"
The article, entitled "How NRx Could Upend the Fight Against Depression and Suicide," can be found at this direct link: https://www.psychiatrist.com/news/how-nrx-could-upend-the-fight-against-depression-and-suicide/.
For more information on $NRXP visit: https://www.nrxpharma.com/ and https://compasslivemedia.com/case-study/nrx-pharmaceuticals/
Media Contact
Company Name: NRx Pharmaceuticals, Inc.
Contact Person: Matthew Duffy, Chief Business Officer
Company Website: https://www.nrxpharma.com/
Email: mduffy@nrxpharma.com
Phone: (484) 254-6134
Home Country: United States
Disclaimer and Disclosure: www.corporateads.com
Aiming to be the First FDA-Approved Medication to Treat Suicidal Depression
Designed to Help Address the Needs of Over 13 Million Americans who Seriously Consider Suicide Each Year (CDC).
Plans to Participate in J.P. Morgan Healthcare Conference on January 13-16, 2025, in San Francisco, CA.
Publication of Paper Entitled "Quality Assurance of Depression Ratings in Psychiatric Clinical Trials."
Featured on Psychiatrist.com: "How NRx Could Upend the Fight Against Depression and Suicide."
NRx Pharmaceuticals, Inc. (Stock Symbol: NRXP) 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. NRXP is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain
NRXP 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, as well as a treatment for complicated UTI.
NRXP is working on a New Drug Application for NRX-100 (IV 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. NRXP 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.
Intravenous ketamine is widely accepted as a standard of care for acute treatment of suicidal depression, in the absence of an FDA-labeled product; the only treatment currently approved by the FDA is electroconvulsive therapy (ECT). According to the CDC, 3.8 million Americans make a plan for suicide each year. This represents a $3-5 billion market at expected pricing. Based on the data in the trials referenced above, the Company's regulatory counsel encouraged the Company to file an NDA for suicidal depression for NRX-100.
More on Washingtoner
- New Tribute Song Celebrating Seattle'
- New analysis reveals second job workers keep just 80p in every pound they earn
- NRE Health Institute Launches International Study Examining Motivations Behind Non-Sexual Nudity
- A Foundational Claim in Human Secrecy Goes Public
- Agape Leadership Academy Opens Nationwide Enrollment — State ESA Scholarships Cover Full Tuition for Families in 7 States
Initial Section of U.S. New Drug Application to the FDA for NRX-100 (IV Ketamine) for the Treatment of Suicidal Depression
On December 30th NRXP announced the transmission of first section of its New Drug Application (NDA) for NRX-100 (ketamine) for electronic filing with the U.S. Food & Drug Administration (FDA). NRX-100 was initially granted Fast Track Designation in 2017 for use in combination with NRX-101 (D-cycloserine/lurasidone) for treatment of suicidal bipolar depression. The Company is now seeking to expand the indication to include Suicidal Ideation in Major Depressive Disorder and other forms of depression, based on data from NIH- and European Government-funded trials that have been summarized on the NRXP website.
While assembly of the clinical data sections is being completed, FDA has asked the Company to submit the 1800-page manufacturing section (Module 3) of the NDA to enable immediate review prior to submission of final efficacy data and other sections of the NDA expected in the first quarter of 2025.
The NRx presentation of ketamine differs from the form of ketamine used in anesthesia in that it contains no potentially toxic preservatives and utilizes diversion-resistant packaging to enhance the traceability of a medicine known to have abuse potential.
Publication of Paper Entitled "Quality Assurance of Depression Ratings in Psychiatric Clinical Trials"
On November 25th NRXP announced the publication of a paper by Sapko, et. al. in the peer-reviewed American Journal of Clinical Psychopharmacology. The paper, entitled "Quality Assurance of Depression Ratings in Psychiatric Clinical Trials,"1 reported on the impact of a comprehensive program developed by NRx Pharmaceuticals to enhance reliability in psychometric ratings that are key to drug approval. Registration trials of drugs for depression and related conditions frequently fail because of unexpected statistical variability across study sites. NRx developed a methodology for training and monitoring the performance of the study site raters, whose measurements are key to the success or failure of all clinical trials of antidepressant drugs. This approach resulted in an unprecedented level of agreement (3 points or better on a 60 point scale) compared to prior industry practices.
More on Washingtoner
- Las Vegas Headliner Don Barnhart Brings National Touring Comedy Show to Comedy Cabana
- Nevada Boxing Hall of Fame Announces 14th Annual Induction Gala Weekend Honoring Classes of 2025 and 2026
- Brosix Celebrates 20 Years of Private Team Messaging for Small and Mid-Sized Businesses
- Top 15 Mosquito-Infested Cities in Louisiana and East Texas Ranked for 2026 Mosquito Season
- From Broken to Soaring Week 40
In the NRX-101 study, trial concordance, as defined by no more than 3 points of disagreement between site raters and central raters, was seen in 94.5% of ratings, where standard industry practice was to accept substantially higher variance (i.e. up to 6 points of disagreement) between study site raters and central raters.2 Accepting higher variance entails recruiting many more participants to achieve statistical significance with substantially higher study costs and risks of failure. NRXP will be using this improved methodology in future drug development, and clinical trials conducted within its network of HOPE clinics.
NRx Pharmaceuticals, Inc. Featured on Psychiatrist.com: "How NRx Could Upend the Fight Against Depression and Suicide"
The article, entitled "How NRx Could Upend the Fight Against Depression and Suicide," can be found at this direct link: https://www.psychiatrist.com/news/how-nrx-could-upend-the-fight-against-depression-and-suicide/.
For more information on $NRXP visit: https://www.nrxpharma.com/ and https://compasslivemedia.com/case-study/nrx-pharmaceuticals/
Media Contact
Company Name: NRx Pharmaceuticals, Inc.
Contact Person: Matthew Duffy, Chief Business Officer
Company Website: https://www.nrxpharma.com/
Email: mduffy@nrxpharma.com
Phone: (484) 254-6134
Home Country: United States
Disclaimer and Disclosure: www.corporateads.com
Source: Corporate Ads
0 Comments
Latest on Washingtoner
- Heritage at South Brunswick Unveils Luxury Resort-Style Amenities Designed for Every Generation
- Spokane: Working Smoke Alarms Help Seven Escape Early-Morning House Fire
- CAPHRA warns push for ASEAN vape ban ignores science
- Spokane: Egypt National Team to Hold Open Training Session at Gonzaga University Ahead of FIFA World Cup 2026™
- Your Mortgage Toolbox Launches Free Mortgage Calculators That Show the Real Monthly Payment and Cash Needed to Close
- ENTOUCH Recognized on Inc.'s 2026 Best Workplaces List for the Third Year Running
- P-Wave Classics Opens Pre-Orders for Volume II of Robert Bage's Hermsprong
- City of Spokane Launches New Webpage, Notice Document to Connect Residents with Eviction Prevention Resources
- Tuckwell Machinery Launches New Range of Woodworking Machinery
- A Brave Little Hero with Four Paws
- Arux Group CEO Calls on Security Industry to End Hidden Subcontracting and White-Papering
- Revenue Optics Expands Its Private Equity Practice as Sponsors Move Inside Sales to the Center of Distribution Value Creation
- Ecuador Freedom Launches First Scheduled Motorcycle Tour of Northern Peru's Lost Kingdoms
- Lineus Medical Completes Financial Restructuring with KMF Investments- Launching a New Era for SafeBreak
- Neuro Recovery Institute Showcases Emerging Immersive Neuro-Rehabilitation Technology at Clinical Innovation Open House
- Community, Conservation & Waterwise Inspiration Bloom on June 6
- Industrial and systems engineers celebrate key leaders in the field at IISE Annual Conference
- Cosanostra Miami Rises as the Best Latin Nightclub in Miami in Under Two Years From its Opening
- CCHR Leader's 50-Year Fight for Psychiatric Drug Victims Gains National Momentum
- Author Releases 7-Day Screen Time Reset for Families as Teachers Worldwide Report Children "Struggling to Grasp Basic Concepts"