HOPE Therapeutics and NRx Pharmaceuticals Align with FDA on Pediatric NRX-100 Study

NRx Pharmaceuticals, Inc., a clinical-stage pharmaceutical company, announced a communication from the US Food and Drug Administration (FDA) regarding their initial Pediatric Study Plan (iPSP) for NRX-100 (ketamine) intended for treating suicidal depression in adolescents. The submission of this iPSP is a prerequisite for filing a New Drug Application (NDA), as mandated by the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA).

Suicide among adolescents is a growing crisis in the United States. The US Centers for Disease Control reports that 10% of high school students attempted suicide in the past year, with 22% having seriously considered it. The highest percentages were noted among females (30%), American Indians/Alaska Natives (27%), and lesbian, gay, or bisexual teens (45%) in 2023.

In preparation for the NDA filing, NRx will provide existing data supporting the safety and efficacy of ketamine for treating suicidal depression in adults. The FDA has acknowledged the severe public health issue of adolescent suicide. As a result, NRx and HOPE Therapeutics will conduct a clinical trial involving adolescents aged 9-17 suffering from suicidal depression. This trial will not extend to younger age groups until NRX-100 receives initial approval for adults. Additional studies on neurotoxicity in juvenile animal subjects will be carried out to ensure the safety of intravenous ketamine for younger patients.

Prof. Jonathan Javitt, Chairman of NRx Pharmaceuticals and Co-CEO of HOPE Therapeutics, emphasized the critical situation of youth suicide in the United States, highlighting a 62% increase over the past two decades, which disproportionately affects minorities. He expressed gratitude for the FDA’s recognition of the urgent need for medical solutions to address suicidal depression in adolescents and reaffirmed the commitment of NRx and HOPE Therapeutics to preventing needless deaths among America's youth.

NRx Pharmaceuticals is a clinical-stage biopharmaceutical company that focuses on developing therapeutics for central nervous system disorders. These include treatments for suicidal bipolar depression, chronic pain, and PTSD, based on its NMDA platform. One of the company’s key developments is NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file for Accelerated Approval for NRX-101 for patients with bipolar depression and suicidality or akathisia. Additionally, NRX-101 shows potential as a non-opioid treatment for chronic pain and a treatment for complicated urinary tract infections (UTIs).

Recently, NRx announced plans to submit an NDA for NRX-100 (IV ketamine) to treat suicidal depression. This submission is based on results from controlled clinical trials conducted under the US National Institutes of Health and new data from French health authorities, obtained through a data-sharing agreement. The US FDA awarded Fast Track Designation for developing NRX-100, recognizing its potential to treat acute suicidality.

HOPE Therapeutics is a care delivery company developing a network of clinics that offer ketamine and other therapies for suicidal depression and related disorders. The company incorporates a digital therapeutic-enabled platform to enhance and maintain the clinical benefits of NMDA-targeted drug therapy.