Popular on Amzeal
- New Book Further Unravels the Myth of a "Chemical Imbalance" Causing Depression
- Retrospec Appoints Nick Marvik as New Head of Growth to Lead eCommerce Expansion
- Connected Technologies Delivers Cutting-Edge Technology to Landmark Properties' Student Housing Communities
- AI pioneer & tech icon, Professor Chris Imafidon speaks on President Trump's $500 Billion AI project
- Enter the Dragon - PermianMuseum.com adds a Winged Dragon Fossil
- How Technology is Making the Florida Court System More Accessible
- LAIIER Closes Oversubscribed US$4M Seed Extension Funding Round, Led by Closed Loop Partners
- The Power Of Online Reviews & Why They Matter
- Osaretin Agbonavbare's AI NGO Makes History at Trump's Presidential Inauguration Ceremony
- Mayo Clinic emergency medicine physician, AI expert highlight international healthcare conference
Similar on Amzeal
- Rutgers University Student Wins "New Jersey's Top Student Entrepreneur" in EO's Global Student Entrepreneur Awards
- Global Digital Currency & Wealth Management Leader; Breakout 388% FY2025 Revenue Growth Over $19.7 Million: Metalpha Technology (Stock Symbol: MATH)
- Zezgo Rent A Car has arrived In Cyprus to Improve Car Rental Options
- Andre Kay Honored with Black Excellence Award by the Florida Panthers
- Wide range of dental care products at upto 40% discounted prices | DentistryDeal.com
- NaturismRE, ANF, and GNA Stand United for Naturist Rights in Australia – A Call for Global Support
- Volante of Hanover Expands with the Opening of Its Second Building, Introduces Assisted Living Services
- Talent Concierge® Artists Agency and The Big Talk® Announce Game-Changing Partnership Challenging Status Quo in the Meetings Industry
- FlyBright Pilot Academy Partners with Allegiant Air to Address the Pilot Shortage
- Uhland Pop Shop Launches February 11, 2025, Bringing Local Pride to Uhland, TX
New Drug Application to the FDA for the Treatment of Suicidal Depression that Affects 13+ Million Americans Each Year: NRx Pharma: Stock Symbol:NRXP
Amzeal News/10585267
$NRXP: Completion of NDA Filing Expected in First Quarter of 2025
MIAMI - Amzeal -- 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 Amzeal 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 Amzeal 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 Amzeal News
- OEM Technology Partnerships Launches Brokerage Specializing in 100+ OEM Technologies
- Cura HR's CEO, Lyssa Hansard, Featured in Forbes: Driving Meaningful Change in Pay Equity
- G2 Names OpenWater a Winter 2025 Leader in Awards and Scholarship Management
- Zezgo Rent A Car has arrived In Cyprus to Improve Car Rental Options
- Meredith Thomas Returns as Master of Ceremonies for International Women's Day Gala for 2025
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 Amzeal News
- Kim Estes Returns as Master of Ceremonies for International Women's Day Gala for 2025
- Andre Kay Honored with Black Excellence Award by the Florida Panthers
- Media Advisory Pastor Mark Burns to Deliver Remarks at BEYA Stars and Stripes Dinner What: The BEYA Stars and Stripes
- Wide range of dental care products at upto 40% discounted prices | DentistryDeal.com
- NaturismRE, ANF, and GNA Stand United for Naturist Rights in Australia – A Call for Global Support
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 Amzeal News
- Uhland Pop Shop Launches February 11, 2025, Bringing Local Pride to Uhland, TX
- Nova Health Labs Welcomes New Advisory Board Members to Drive Patient-Centered Innovation
- C-BATT joins NAATBatt, the premier US Battery Trade Association
- Partnerships to Launch Digital Entertainment Hub in China; $40 Million Investment into Global MOBA Digital Game Arena: NIP Group (Stock Symbol: NIPG)
- Sip Social Co. Brings Refreshing Energy to the Miami Marathon Finish Festival with FP Movement
- Igniting Souls® and EOS Worldwide® Launch EOS Impact™: The Exclusive Publishing Collaboration for 850+ EOS Implementers
- Ceramic Liberty Unveils CL8Y: A Revolutionary Deflationary Memecoin Set to Redefine DeFi
- International Women's Day Gala to Celebrate Women's Achievements and Support Fire Survivors
- Sidow Sobrino Unleashes Bite After Bite, a Captivating Music Video & Song from His 12th Studio Album, Seminal
- How New U.S. Tariffs Are Reshaping the Frequency Control & Precision Timing Industry
- L-Tron welcomes Senator Pam Helming to their Victor, NY Office
- PCnet Supports Business Growth with Reliable Managed IT Services
- New Jersey Sober Living Opens New Luxury Themed Facility in South New Jersey
- Atlanta Students to Talk with Astronauts on International Space Station
- Hawaii Bill Marks Progress in Protecting Patients From Dangerous Restraint Practices
- All me - secure anonymous social - kickstarter crowdfunding
- HomeFortis Launches Target Hardening Guides for Home Security
- Retired Leadership Facilitator Shares Decades of Wisdom in New Book
- CCG Relaunches Spring Virtual Recruitment Fair to Connect Employers with Top STEM, AI, and Veteran Talent
- The AI Revolution: How ChatGPT-Like Tools Will Transform Industries by 2030