NRx Pharmaceuticals Announces Signing of a Data and Technical Information Agreement with Columbia University Accessing Key Data Demonstrating Efficacy and Safety of Intravenous Ketamine for the Treatment of Suicidal Depression

Rhea-AI Summary

NRx Pharmaceuticals, Inc. (NRXP) announced the signing of a License Data and Technical Information Agreement with Columbia University for rights to data from a randomized, active-controlled trial of 80 patients hospitalized for Acute Suicidality in Depression. The trial demonstrated a rapid and statistically significant reduction in Suicidal Ideation (SSI) at day 1 (p=0.0003) and in depression (P=0.0234) among patients randomized to IV Ketamine compared to those randomized to midazolam. NRx plans to present the data from these two trials to FDA in support of a New Drug Application to be filed in q1 2024.

Positive

• The well-controlled trials demonstrate the efficacy of IV Ketamine in treating suicidal depression.
• The results of the trials were published in reputable medical journals, adding credibility to the findings.

Negative

• There is no mention of potential side effects or risks associated with IV Ketamine treatment.
• The need for FDA approval and the potential impact on the company's financials are not discussed in detail.

Pharmaceutical Analyst

The recent findings from NRx Pharmaceuticals regarding the efficacy of IV Ketamine in reducing acute suicidality and depression are indicative of a potential shift in treatment paradigms. The statistically significant results, particularly the p-value of 0.0003 for suicidality, suggest a robust effect size that could lead to a strong value proposition for the drug if approved by the FDA. Such approval could disrupt the current market for depression treatments, which is significant given the prevalence of the condition and the limited efficacy of existing interventions for acute suicidal ideation.

Investors should note the strategic collaboration with Columbia University, which could enhance the credibility of the research and increase the likelihood of regulatory success. Furthermore, the comparison to ECT, a current standard for severe cases, positions Ketamine as a less invasive alternative with a more favorable side effect profile. This could result in a rapid uptake upon approval, impacting NRx's market share and revenue potential.

However, challenges remain, including the stigma associated with Ketamine's recreational use and the need to establish a clear safety profile. Also, the necessity for IV administration could limit accessibility compared to oral medications. Long-term, the differentiation of Ketamine in the treatment of suicidality could lead to a reevaluation of treatment guidelines and insurance coverage, potentially expanding the addressable market.

Clinical Psychologist

The clinical implications of the reported trial results for IV Ketamine are profound, especially considering the rapid reduction in Suicidal Ideation. From a mental health perspective, the speed of therapeutic effect is critical in acute situations and Ketamine's performance could represent a significant advancement in crisis intervention. The psychological community will likely scrutinize these findings, given the high stakes involved in treating acute suicidality.

For healthcare providers and patients, the accessibility of Ketamine treatment hinges on FDA approval and subsequent insurance coverage. The cost barrier for out-of-pocket payment is a significant consideration, as it could limit the treatment's availability to a broader patient population. Should Ketamine become an FDA-approved option, it would likely lead to a reevaluation of treatment protocols and could become a first-line treatment in certain scenarios.

One must also consider the potential for Ketamine to change the public perception of treatment for suicidality and depression. If the side effect profile is indeed more benign than ECT and other treatments, it could reduce the reluctance of patients to seek help. This could have a ripple effect on public health outcomes and the overall burden of mental health conditions on society.

Healthcare Policy Expert

The strategic moves by NRx Pharmaceuticals to position IV Ketamine for FDA approval carry significant implications for healthcare policy. The existing treatment gap for acute suicidality and depression represents a public health challenge and the introduction of an effective and rapid treatment could alter national health strategies. Policymakers and insurance companies will need to evaluate the cost-effectiveness and health outcomes associated with approving and covering a new treatment modality.

Moreover, the regulatory landscape is influenced by both clinical evidence and public health needs. The data from these trials could catalyze discussions on mental health crisis management, potentially leading to new policies that support faster and more accessible interventions for those at risk of suicide.

From a long-term perspective, the approval of Ketamine could necessitate additional research into optimal treatment protocols, including dosage, frequency and combination with other therapies. It could also prompt a reevaluation of mental health resource allocation and training for healthcare professionals to administer IV treatments in various settings.

• Ketamine, an NMDA blocker, was highly effective compared to active comparator in rapidly reducing Suicidality (p=0.0003)
• This study represents the second well-controlled trial NRx has licensed supporting the use of IV Ketamine in suicidal depression
• NRx plans to present the data from these two trials to FDA in support of a New Drug Application to be filed in q1 2024

RADNOR, Pa., Dec. 19, 2023 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it has signed a License Data and Technical Information Agreement with Columbia University for rights to data from a randomized, active-controlled trial of 80 patients hospitalized for Acute Suicidality in Depression. This represents NRx's second well-controlled trial demonstrating the efficacy of IV Ketamine in this indication.

In this trial, Dr. Michael Grunebaum and colleagues demonstrated a rapid and statistically significant reduction in Suicidal Ideation (SSI) at day 1 (p=0.0003) and in depression (P=0.0234), as measured by the Profile of Mood States (POMS) among patients randomized to IV Ketamine compared to those randomized to midazolam.  This trial was published in the American Journal of Psychiatry https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5880701/.

These data mirror the results recently reported by a French consortium of hospitals who tested ketamine vs. placebo in acutely suicidal patients. NRx established a similar data licensing agreement in September, 2023 (NRx Ketamine Data Sharing, France).  The study was published in the British Medical Journal (BMJ 2022; 376 doi: https://doi.org/10.1136/bmj-2021-067194). 

The company and its regulatory counsel believe these two well-controlled trials meet the regulatory standard for a New Drug Application (NDA) filing in early 2024.  This filing will include manufacturing and stability data from the Company's partnership with Nephron Pharmaceuticals (West Columbia, SC).

"We at NRx are delighted to partner with the thought leaders at Columbia University to help seek FDA approval for this extraordinary public health need. Until now, the only FDA-approved treatment for suicidal depression has been electroshock therapy (ECT). Recent literature suggests that ketamine may actually be superior to ECT in reducing suicidal ideation, while certainly having a more benign side effect profile," said Dr. Jonathan Javitt, Founder and Chief Scientist of NRx Pharmaceuticals. "Although ketamine is widely used off-label in the United States and is considered standard of care by some professionals, until it is labeled for treating depression and suicidality it will be widely accessible only to those patients able to pay out of pocket for their care and will continue to be subject to various warnings about off label use of a controlled substance."

Additional information about this initiative can be found on the Company's website Ketamine FAQs.

About NRx Pharmaceuticals
NRx Pharmaceuticals 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. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx 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.

NRx has recently announced plans to submit a New Drug Application for 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. NRx 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.

Cautionary Note Regarding Forward-Looking Statements

This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the Company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the Company's management. 

The Company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above.

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SOURCE NRx Pharmaceuticals

FAQ

What is the significance of the License Data and Technical Information Agreement signed by NRx Pharmaceuticals, Inc. (NRXP) with Columbia University?

The agreement grants NRx access to data from a well-controlled trial of IV Ketamine in treating Acute Suicidality in Depression, demonstrating its efficacy.

What are the findings of the trial regarding the use of IV Ketamine in reducing Suicidal Ideation (SSI)?

The trial showed a rapid and statistically significant reduction in Suicidal Ideation (SSI) at day 1 (p=0.0003) and in depression (P=0.0234) among patients randomized to IV Ketamine compared to those randomized to midazolam.

What are the plans of NRx Pharmaceuticals, Inc. (NRXP) regarding the data from the trials and FDA approval?

NRx plans to present the data from these two trials to FDA in support of a New Drug Application to be filed in q1 2024.

What is the expert opinion on the use of IV Ketamine for treating suicidal depression?

Dr. Jonathan Javitt, Founder and Chief Scientist of NRx Pharmaceuticals, believes that ketamine may be superior to ECT in reducing suicidal ideation and has a more benign side effect profile.

What are the potential risks or side effects associated with the use of IV Ketamine?

There is no mention of potential side effects or risks associated with IV Ketamine treatment in the press release.