Popular on TelAve
- Century Fasteners Corp. Exhibiting at the 2025 International Paris Air Show
- Pregis Empowers Foam-in-Place Customers to Fight Water Insecurity with Inspyre Film
- Fusion Marketing Group Celebrates 15 Years of Transforming Healthcare Recruitment Marketing
- Kaplan Morrell Applauds Passage of Landmark Workers' Compensation Reform in Colorado
- Experience Trembling Firsthand with the New AgeMan® Tremor Simulator
- Western Carolina Emergency Network Accepts 2025 ReadyCommunities Partnership/CCROA National Service Award for Collaboration to Augment Local Response
- $3.9M Q1 2025 Revenue Following $39M in Cybersecurity Contracts for Education and Transportation Sectors: Cycurion, Inc
- Manhattan Boutique Real Estate Collaborates with InterContinental Hotels NYC in a Branding Partners Personalized Approach
- TEDxInglewood Returns to The Miracle Theater on August 9, 2025 — Celebrating Bold Ideas and Community Energy
- Rediscovered Christopher Lee Recording 'Elenore' Re-Released to Mark 10th Anniversary of His Passing
Similar on TelAve
- Real Estate Experts Highlight Jersey Shore as a Smart Buy in 2025
- $18 Price Target Issued in New Research Report After $34 Million Revenue Forecast from Acquisition; $101.5 Million Net Revenue in 2025; NAS DAQ: IQST
- West Dentistry Welcomes New Oral Surgeon to Enhance Patient Care
- The AML Shop Launches New Financial Investigations Unit, Appoints Director to Lead the Initiative
- Raidium révolutionne le diagnostic de la Sclérose en Plaques en partenariat avec l'Hôpital Fondation Adolphe de Rothschild
- New Podcast "Spreading the Good BUZZ" Hosted by Josh and Heidi Case Launches July 7th with Explosive Global Reach and a Mission to Transform Lives
- Digital Watchdog Launches New myDW Cloud Services
- Drone Light Shows Emerge as the New Standard in Live Event Entertainment
- Skyline Partners with ZenSpace to Offer Private Meeting Pods for Trade Show Exhibitors
- AI Innovation Dual-Strategy Business Model Focused on Real Estate Development for Strategic Expansion: OFA Group, (N A S D A Q: OFAL)
New Drug Application to the FDA for the Treatment of Suicidal Depression that Affects 13+ Million Americans Each Year: NRx Pharma: Stock Symbol:NRXP
TelAve News/10850089
$NRXP: Completion of NDA Filing Expected in First Quarter of 2025
MIAMI - TelAve -- 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 TelAve News
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 TelAve News
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 TelAve News
- Raidium révolutionne le diagnostic de la Sclérose en Plaques en partenariat avec l'Hôpital Fondation Adolphe de Rothschild
- New Podcast "Spreading the Good BUZZ" Hosted by Josh and Heidi Case Launches July 7th with Explosive Global Reach and a Mission to Transform Lives
- The Herbal Care, Led by Markel Bababekov, Becomes a Top Dispensary in NYC's Upper East Side
- Digital Watchdog Launches New myDW Cloud Services
- Stan Fitzgerald Appointed Acting Press Secretary for Veterans for America First VFAF Georgia State Chapter
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 TelAve News
- Drone Light Shows Emerge as the New Standard in Live Event Entertainment
- Lore Link is Here to Help Organize Your Game
- Chappaqua's Annual Townwide Summer Sale – Unbeatable Savings at Your Favorite Local Boutiques!
- Skyline Partners with ZenSpace to Offer Private Meeting Pods for Trade Show Exhibitors
- AI Innovation Dual-Strategy Business Model Focused on Real Estate Development for Strategic Expansion: OFA Group, (N A S D A Q: OFAL)
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
Filed Under: Business
0 Comments
Latest on TelAve News
- Plan to Launch Silo Technologies' Cybersecurity Pilot Program for Ultimate Nationwide Deployment via Exclusive Partnership: Stock Symbol: BULT
- Robert Michael & Co. Real Estate Team Celebrates Industry Recognition and Showcases Premier Central Florida Listings
- AI-Based Neurotoxin Countermeasure Initiative Launched to Address Emerging National Security Needs: Renovaro, Inc. (N A S D A Q: RENB)
- The Naturist World Just Shifted — NaturismRE Ignites a Global Resurgence
- Ace8 Launches Cutting-Edge Observability Service to Empower Modern IT Operations
- AceMQ Unveils Advanced Containerization Solutions to Accelerate Digital Transformation
- $796,000 in Q2 Revenue Marks Highest Earnings to Date on 3 Trailing Quarters of Profitability in Multi-Billion Homebuilding Sector: Stock Symbol: IVDN
- Cybersecurity is THE Hot Market Sector; Revenues, Earnings & Profit matter; Only 33 Million Shares + a Huge Short Position Equal an Undervalued Stock
- Despite Global Calls for a Ban, US Child Psychiatry Pushes Electroshock for Kids
- Franco Polished Plaster Celebrates 35 Years of Bringing Walls to Life in the UK
- Spartan & Guardians Partner with Guitar Legend Buckethead to Support Global Child Rescue Efforts
- Preliminary.online Introduces Short-Term Job-Readiness Courses with Employer-Verified Certifications
- Psychologist-Turned-Hermeticist Releases Modern Guide to the Seven Hermetic Principles
- Winners Announced for Asia Pacific Business Awards 2024-2025
- Hamvay-Lang and Lampone.hu Join Forces with AIMarketingugynokseg.hu to Elevate Hungarian Lifestyle Brands on the Global Stage
- Google AI Quietly Corrects the Record on Republic of Aquitaine's Legal Sovereignty
- NYC Leadership Strategist Stacie Selise Launches Groundbreaking 4S Framework Series to Redefine Executive Excellence
- Make Innovation Matter: Support H.R.1's R&D Expensing Relief for American Small Businesses
- Agreement to Supply US-Based Defense Provider with Thin-Film Solar Tech for Orbital Application; Ascent Solar Technologies, Inc. (N A S D A Q: ASTI)
- Byrd Davis Alden & Henrichson Launches Independence Day Safe Ride Initiative with 500 Free Uber Credits