RADNOR, PA — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) announced that the U.S. Food and Drug Administration (FDA) has provided positive feedback and alignment on its proposed initial Pediatric Study Plan (iPSP) for NRX-100 (ketamine) aimed at treating suicidal depression in adolescents. The iPSP submission is a required step before 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 public health crisis in the United States. The Centers for Disease Control and Prevention (CDC) reports that 10% of high school students attempted suicide in the past year, and 22% seriously considered it. The rates are particularly high among females, American Indians/Alaska Natives, and LGBTQ+ teens.
In preparation for its NDA filing, NRx will submit existing data showing the safety and efficacy of ketamine in treating suicidal depression in adults. The FDA has recognized the rising concern of adolescent suicide and has agreed that NRx and HOPE Therapeutics will conduct a clinical trial of NRX-100 for adolescents aged 9-17 with suicidal depression. The study will not require testing on younger age groups initially. Additional neurotoxicity studies will be conducted using juvenile animal subjects to ensure the safety of intravenous ketamine for younger patients.
“Youth suicide has reached crisis proportions in the United States with a 62% increase over the past two decades, disproportionately affecting minorities,” said Prof. Jonathan Javitt, Chairman of NRx Pharmaceuticals and Co-CEO of HOPE Therapeutics. “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.”
This alignment with the FDA is a significant step forward in addressing a critical public health issue and could pave the way for new treatment options for suicidal depression in adolescents.
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