Breakthrough Medicines for Suicidal Bipolar Depression, Chronic Pain & PTSD: NASDAQ: NRXP $NRXP

NRx Pharmaceuticals, Inc. (NASDAQ: NRXP)

WILMINGTON, DELAWARE, UNITED STATES, February 8, 2024 /EINPresswire.com/ -- Clinical Stage Biopharmaceutical Company Focused on Breakthrough Medicines for Suicidal Bipolar Depression, Chronic Pain and PTSD: NRx Pharmaceuticals, Inc. (Nasdaq: NRXP)

For more information on $NRXP visit: https://www.nrxpharma.com/

NRXP Corporate Presentation:
https://www.nrxpharma.com/wp-content/uploads/NRx-Corporate-Presentation.pdf

Developing Therapeutics for the Treatment of CNS Disorders, Specifically Suicidal Bipolar Depression, Chronic Pain and PTSD.

Incorporation of HOPE Therapeutics Dedicated to NRX-100 (IV Ketamine) for Suicidal Depression to Patients.

HOPE Therapeutics to be Initially Owned by NXRP and current NXRP Shareholders via a Planned Tax-Free Dividend.

New Drug Application for NRX-100 Expected to be Filed in 1st Half of 2024.

Completion of Enrollment for Phase 2b/3 Trial of NRX-101 in Suicidal Treatment Resistant Bipolar Depression.

Positive Data Triggers Milestone Payment from Alvogen.

NRx Pharmaceuticals, Inc. (Nasdaq: 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 has recently announced plans to submit 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.

Incorporation of HOPE Therapeutics & Planned Share Dividend/Royalty Coupon

On February 5th NRXP announced the incorporation of HOPE Therapeutics™, a biotechnology company dedicated to bringing NRX-100 (IV Ketamine), which will be re-designated HTX-100, a potentially lifesaving treatment option for patients with Suicidal Depression. The company will initially be owned by NRXP and its current shareholders, who will receive their shares in the form of a dividend with an accompanying royalty coupon tied to future sales of HTX-100, subject to Board approval. This is designed with counsel to not be a taxable event for NRXP shareholders.

HOPE is dedicated to providing an FDA-approved presentation of IV Ketamine, manufactured to current federal standards, in a diversion- and abuse-deterrent presentation. A New Drug Application (NDA) is planned for the first half of 2024, based on more than 1,000 patients treated in well-controlled trials of ketamine in Suicidal Depression together with HOPE's expertise in sterile products formulation.

Importantly, NRXP intends to provide state-of-the-art patient and reimbursement support for all of its patients and their clinics. Access to insurance coverage is critical for providing treatment to this vulnerable population and can only be achieved through development of an FDA-approved product. Additionally, providing an approved, compliant product for patients allows clinics to deliver state-of-the-art care to people suffering from suicidality without fear of legal and regulatory actions.

Completion of Enrollment for Phase 2b/3 Trial of NRX-101 in Suicidal Treatment Resistant Bipolar Depression

On January 22nd NRXP announced completion of enrollment in its Phase 2b/3 study of NRX-101, the Company's patented combination of the NMDA antagonist D-cycloserine and lurasidone, in Suicidal Treatment Resistant Bipolar Depression. Enrollment of 74 patients exceeded the original target of 70 patients, in order to enhance statistical power of the study. As previously disclosed, positive data from this trial triggers a milestone payment from Alvogen. Alvogen will then be responsible for further development and commercialization costs for this program.

The NRXP Phase 2b/3 trial (www.clinicaltrials.gov NCT 03395392) enrolled 74 patients with suicidal bipolar depression. This is a randomized, prospective, multicenter, double-blind study comparing NRX-101 to lurasidone over six weeks. The Principal Investigator is Prof. Andrew Nierenberg of Harvard Massachusetts General Hospital. The primary efficacy endpoint is reduction in depression as measured on the MADRS scale and the secondary endpoint is reduction of suicidal ideation as measured by the Clinical Global Impression Suicidality Scale (CGI-SS). As previously disclosed, treatment compliance and concordance of local raters to central raters scores was in excess of 94%, well above the industry standard that is normally seen in CNS trials.

Top-line results from the NRXP clinical trial are expected later this quarter.


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SOURCE: CorporateAds.com

Matthew Duffy, Chief Business Officer
NRx Pharmaceuticals, Inc.
+1 484-254-6134
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