• FDA response highlights the importance of addressing suicidal depression in adolescents age 9-17
• Alignment on initial Pediatric Study Plan (iPSP) is a gating requirement for the upcoming filing of an NRX-100 New Drug Application (NDA) for suicidal depression
• NRx remains on track to file the NDA for NRX-100 in Q4 2024 with anticipated PDUFA date in Q2 2025

RADNOR, Pa., July 29, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical stage pharmaceutical company, today announced a communication from the US Food and Drug Administration (FDA) providing feedback and alignment on NRx's proposed initial Pediatric Study Plan (iPSP) for NRX-100 (ketamine) in the treatment of suicidal depression. Congress required the submission of an iPSP as a precondition to filing a New Drug Application in the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA).[1]

Suicide is a growing crisis among adolescents in the United States. According to the US Centers for Disease Control, 10% of high school students attempted suicide in the past year and 22% of high school students reported having seriously considered suicide. This percentage is highest among females (30%), American Indians/Alaska Natives (27%), and lesbian, gay, or bisexual teens (45%) (CDC, 2023). [2]

In support of its upcoming NDA filing, NRx will be submitting existing data supporting the safety and efficacy of ketamine to treat suicidal depression in adults. FDA has now documented its recognition that suicide is a serious and growing public health concern in adolescents as well. Based on the guidance received, NRx and HOPE Therapeutics will commit to conducting a clinical trial of NRX-100 in adolescents aged 9-17 with suicidal depression, but will not be required to study the effects of NRX-100 in younger age groups, following initial approval of NRX-100 in adults. Additional neurotoxicity studies will be conducted in juvenile animal subjects to support the safety of intravenous ketamine in this younger population.

"Youth suicide has reached crisis proportions in the United States with a 62% increase over the past two decades, disproportionately affecting minorities.[3] 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, said Prof. Jonathan Javitt, Chairman of NRx Pharmaceuticals and Co-CEO of HOPE Therapeutics."

About NRx Pharmaceuticals, Inc.

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 plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.

NRx has recently announced plans to submit a New Drug Application for NRX-100 (IV ketamine) for 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.

About HOPE Therapeutics, Inc.

HOPE Therapeutics, Inc. (www.hopetherapeutics.com)  is a care delivery company developing a best-in-class network of clinics that currently offer ketamine and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.

Notice Regarding Forward-Looking Statements

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¹ https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/Pediatric-Study-Plans--Content-of-and-Process-for-Submitting-Initial-Pediatric-Study-Plans-and-Amended-Pediatric-Study-Plans.pdf 
² https://www.cdc.gov/healthyyouth/data/yrbs/pdf/YRBS_Data-Summary-Trends_Report2023_508.pdf
³ https://www.apa.org/monitor/2023/07/psychologists-preventing-teen-suicide