Trending...
- Spokane: Camp Sekani Update 7/9/26
- Stigma Across Borders: Concerns Grow Over Discrimination Against Shincheonji Members Abroad
- Tacoma: Statement from At-Large Council Member Latasha Palmer and At-Large Council Member Olgy Diaz Regarding Stand-Alone Data Centers
$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 Thriller 'Counterframe' Explores the Hidden Vulnerabilities of Modern Society
- Tacoma: Arrest Made in Connection with 2024 Homicide
- Award-Winning Heritage at South Brunswick Continues to Thrive as One of New Jersey's Premier New Home Communities
- Four Seasons Cleaners Debuts Santa Barbara County's First 24/7 Dry Cleaning Kiosk New self-service
- WhereTu Launches to Help Americans Build Successful Lives Abroad
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
- Appliance EMT Expands Built-In and Walk-In Refrigerator Service in Metro Atlanta
- LawProactive Launches SB 37-Compliant Attorney Marketing Software With Exclusive City Territories Across California
- Cogs and Marvel expands EMEA leadership team for next phase of growth
- Dave Freer's "Storm-Dragon" Wins First-Ever Prometheus Special Award For Young Adult Fiction
- T. Jones Group Celebrates Two Wins and Multiple Project Nominations at the 2026 HAVAN Awards
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
- Kolbus Introduces the Next Step in Casemaking Efficiency
- Spokane: Camp Sekani Update 7/9/26
- Florida Law Advisers, P.A. Named Best Divorce Firm of 2026 by Expert Law Attorneys
- Sahar Education Invites You to Celebrate Afghan Culture and Community
- Homicide Arrest – 1000 Block of South Tacoma Way
- City of Spokane, Catholic Charities Showcase Innovative Homeless Outreach Program at National Conference
- MD Marine Electric Announces Rebranding as MD Electric Group
- Sounds of LA County: 27 Parks.108 Concerts. One County
- Only One Flight Stands Between Los Angeles Youth Leaders and a Life-Saving Mission in South Africa
- Stigma Across Borders: Concerns Grow Over Discrimination Against Shincheonji Members Abroad
- Wu-Tang Made One Album for One Buyer. This Band Makes One Original Song for Every Fan
- Tacoma: Preparing the Bid Workshop on July 22
- World Cup Crowds Are a Stress Test for America's Restrooms
- Postmortem Pathology Expands Access to Private Autopsy Services in Las Vegas
- How Sacramento Families Are Using Private Autopsies to Protect Inheritances, Resolve Insurance Claims, and Find Closure
- Los Angeles' Best Food: Food Journal Magazine Examines the Trends Shaping the City's Dining Scene
- Spokane: SPD Make an Arrest in Connection with an Arson that Happened on June 9
- Landmark Construction Expands Glass, Glazing, and Commercial Remodeling Services Across Los Angeles County and Surrounding Areas
- Tacoma: Statement from At-Large Council Member Latasha Palmer and At-Large Council Member Olgy Diaz Regarding Stand-Alone Data Centers
- Tacoma: Homicide Investigation – 6900 Block of East D Street