Trending...
- Monexplora Explains the Options Mechanics Behind March's Tech Selloff and VIX Surge
- City of Spokane And City Council Announce 2026 Washington State Legislative Outcomes
- KeysCaribbean Offers 'Skip-the-Crowds' Savings With 15 Percent Off April Stays
$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
- UK Financial Ltd Tokenized LTNS 1, A $1.1 T Asset-Backed ERC-3643 Security Token with 11 On-Chain Contracts Verifying, Compliant Real-World Value
- SelfCare is now HealthCare across America
- State of TBM 2025 Report: 83% of Organizations Boost Performance & Efficiency
- Spokane: Call for High School Artists: 2026 Riverfront Park Poster Contest
- Spokane: Traffic Impacts Starting Monday, March 30
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
- Homeowner Prep Announces Strategic Language Shift: Replacing "Renters" with "Future Homeowners" to Inspire Wealth-Building Mindsets
- LiposoMore™ Redefines Bioavailability: Joyful Nutritional Launches High-Performance Liposomal Vitamin C and Iron for the Global Supplement Market
- GDE Tree Services Expands Operations into Sydney, NSW
- Tuckwell Machinery Expands CNC Range to Support Australian Cabinet Makers
- The Inner Power of Emotional Self-Leadership
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
- The AAA Metamorphosis: How Global Gaming Is Redefining Production Standards
- Monexplora Explains the Options Mechanics Behind March's Tech Selloff and VIX Surge
- Spokane: Shooting on Wellesley Leaves One Person Deceased and Another Injured
- Spokane: District 3 Council Members to Host Community Town Hall
- Spokane: City Recognizes Local Businesses for Excellent Wastewater Management
- Tacoma Police Department Increases DUI Patrols
- Larry R. Wasion Highlights Jump Gate I: Time Chair. The Opening Novel in His Expansive Science Fiction Series
- New Book Reveals The Science Of Predictions
- City of Tacoma's Solid Waste Utility Expands 'Beyond the Bin' Community Reuse Events
- Animal Communicator Vicki Draper Helps Pet Parents Reduce Stress and Improve Behavior Naturally
- Compliance Alert: Maryland, Texas Regulate Use of Artificial Intelligence in Utilization Reviews
- "FRAUD: Federal Reliance, Regulatory Blindness, ANAB Misrepresentation, Unchecked Conflicts, And Deception -The Guberman Definition
- Colony Ridge Communities Celebrates Successful Soccer Season Kickoff with Families and Youth
- NYC Composer/Educator Launches Debut Children's Book to Fantastic Reviews
- EFA Announces 2026 Editorial Rate Chart
- Red5 Taps PubNub to Power the Next Era of Real-Time Interactive Streaming
- Shoutout Joseph Neibich aka Nybyk
- Meet Joseph Neibich aka Joseph Nybyk of Beachwood Canyon
- City of Spokane And City Council Announce 2026 Washington State Legislative Outcomes
- LARUS Launches Business Continuity Framework for IPv4-Dependent Networks