NRx Receives Response From FDA Over Testing Use of Ketamine for Suicidal Depression in Adolescents

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NRx Pharmaceuticals announced that it has received a response from FDA over its proposed plan to study the impact of ketamine (NRX-100) as a treatment for suicidal depression in adolescents.¹ Congress had previously stated that this is a requirement before NRx can filing a new drug application (NDA) for the use of ketamine to treat suicidal depression.

According to NRx, it will work with Hope Therapeutics to conduct a clinical trial on ketamine’s use for this condition. The study will include participants aged 9-17, but it will not be required to include younger participants. The companies will also conduct studies involving animals to determine the safety of ketamine usage in adolescents.

In a press release, NRx Pharmaceuticals chairman and HOPE Therapeutics co-CEO Prof. Jonathan Javitt said, “Youth suicide has reached crisis proportions in the United States with a 62% increase over the past two decades, disproportionately affecting minorities. We appreciate FDA's recognition of the urgent unmet medical need related to suicidal depression in adolescents and look forward to expanding the mission of NRx and HOPE Therapeutics to serve America's youth in preventing needless deaths from suicidal depression.”

NRx also announced that it will proceed with the spinoff of Hope Therapeutics after a Utah arbitrator denied a petition from Streeterville Captial, LLC, to enjoin NRx from spinning off 49% of the shares of HOPE Therapeutics.²

In a press release, Javitt stated, “As we have previously shared with the public, HOPE Therapeutics is in the process of developing a best-in-class network of clinics that currently offer ketamine and other lifesaving therapies to patients with suicidal depression. This arbitration decision enables us to keep our promise to shareholders to spin out 49% of HOPE Therapeutics shares held by NRx to our shareholders, subject to approval by our Board of Directors and compliance with applicable law. We appreciate the support and loyalty of our shareholders as we work to bring HOPE to life.”

NRx announced that it would be filing the NDA for ketamine in June of this year.³ At the time, the company stated that it based its decision on four positive trials.

At the time, Javitt stated, “The NRx team has worked diligently since the end of the COVID pandemic to achieve these milestones for our shareholders and most importantly the patients we have always sought to help. Given the near-term market opportunity represented by an accelerated approval process, NRx anticipates a higher potential return to NRx investors associated with an NRx-led initiative than that which would likely be achieved with a large commercial partner."

Sources

1. HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (Nasdaq:NRXP) Announce Alignment with FDA on Pediatric Study Plan for NRX-100 (ketamine). NRx Pharmaceuticals. July 29, 2024. https://www.prnewswire.com/news-releases/hope-therapeutics-inc-and-nrx-pharmaceuticals-inc-nasdaqnrxp-announce-alignment-with-fda-on-pediatric-study-plan-for-nrx-100-ketamine-302208338.html
2. HOPE Therapeutics, Inc. and NRx Pharmaceuticals (Nasdaq:NRXP) Announce Arbitration Order Enabling HOPE Therapeutics Spinoff. NRx Pharmaceuticals. July 29, 2024. https://www.prnewswire.com/news-releases/hope-therapeutics-inc-and-nrx-pharmaceuticals-nasdaqnrxp-announce-arbitration-order-enabling-hope-therapeutics-spinoff-302208316.html
3. NRx Pharmaceuticals (NASDAQ:NRXP) to Proceed with Two New Drug Applications in 2024; NRX-101 has Been Returned to the Company for Filing. NRx Pharmaceuticals. June 28, 2024. Accessed July 29, 2024. https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-nasdaqnrxp-to-proceed-with-two-new-drug-applications-in-2024-nrx-101-has-been-returned-to-the-company-for-filing-302185390.html