Trending...
- Spokane: Male In Custody After Puppy Is Thrown From Moving Vehicle During Argument; Puppy Located By Neighbor Unharmed
- Best Personal Injury Attorneys Of 2025 - ELA Awards
- GlobalBoost Media (BSTY) Shows Bullish Signals: Technical Analysis and Exchange Updates
$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
- WinkBeds High-Performance Hybrid Mattresses Debut at Sleep Basil Denver With In-Store Comfort Testing
- Tampa Nonprofit Expands Recovery Services for Men in Crisis With New Farm Program in Plant City
- Applications for 2026-2027 Tacoma Creates Funding Now Available
- Spokane Police Investigating Shooting In North Spokane That Left One Adult Injured
- IYKYK! Coffee Lab Thriving in Huntington Beach, Blending Elevated Coffee, Matcha, Music, and Community
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
- Accountants Near Me Cheyenne Opens U.S. Directory for Accountants, Bookkeepers and Tax Services
- Sacred Surrogacy, CFC, and Egghelpers Launch Women's Retreats
- From the 1950s to Today, Perfect Arrangement Uses Satire to Confront LGBTQ+ and Gender Norms
- Arkero Announces $6 Million Pre Seed Funding Round, Partnerships with major MLS, NWSL and EFL teams
- Stipenda Appoints David Epstein as Chief Operating Officer
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: Financial
0 Comments
Latest on Washingtoner
- STS Capital Partners' Andy Harris Co-Authors 'The Extraordinary Exit,' A Practical Guide for Business Owners Considering a Sale
- One-Click Pro Audio for Streamers: "VoiceSterize" Automates Noise Reduction & Mastering on Mac
- Sole Publishing Announces Essential Parenting Book for Families Navigating the Teen Years
- From Factory Floor to Community Heart: The Rebel Spirit of Wisconsin's Wet Wipe Innovators
- UK Financial Ltd Lists MayaFund (MFUND) ERC-20 Token on CATEX Exchange Ahead of Planned ERC-3643 Upgrade
- Denver Apartment Finders Launches Revamped Denver Tech Center Apartment Location Page
- Roblox and Solsten Alliances; a Stronger Balance Sheet and Accelerated Growth Through AI, Gaming, and Strategic Partnerships for Super League: $SLE
- Boston Industrial Solutions' Natron® 512N Series UV LED Ink Earns CPSIA Certification
- Power Business Solutions Announces Joint Venture with EIG Global Trust to Deliver Data Center Financial Solutions
- Scoop Social Co. Partners with Fairmont Hotels & Resorts to Elevate Summer Guest Experiences with Italian Inspired Gelato & Beverage Carts
- Spokane: Standoff With Domestic Violence Suspect Resolves Peacefully
- Velixo Unveils Velixo Intelligence, Its New AI-Powered Assistants, at Acumatica Summit
- GlobalBoost Media Advances Uncensorable Web on Blockchain with New Exchange Listings
- Buildout Launches Native Email Marketing Feature, Expanding Its End-to-End CRE Platform
- New Saxophone Prize Honors Astronaut Ronald E. McNair, First To Play Sax In Space
- Building a $145M AI-Powered Marine Platform as Listings Surge, Global Expansion Begins, OTH Shares Trade at a Discount: Off The Hook YS (N Y S E: OTH)
- American Disabilities Act Must Protect Against Forced Psychiatric Commitment and Treatment
- 2025 Top Lawyers - ELA Awards by Expert Law Attorneys
- Top Law Firms In 2025 - Expert Law Attorneys
- Best Personal Injury Attorneys Of 2025 - ELA Awards





