NRx Pharmaceuticals Inc (Nasdaq: NRXP) announced on Monday that with HOPE Therapeutics Inc, it has secured alignment with the US Food and Drug Administration (FDA) on the initial Pediatric Study Plan (iPSP) for NRX-100 (ketamine) aimed at treating suicidal depression in adolescents aged 9-17. This agreement is a critical step toward filing a New Drug Application (NDA) for NRX-100, expected in Q4 2024, with a projected PDUFA date in Q2 2025.

The FDA's response underscores the urgent need to address suicidal depression among adolescents. Current data from the US Centers for Disease Control reveal that 10% of high school students attempted suicide last year, with 22% seriously considering it. Rates are notably high among females, American Indians/Alaska Natives, and LGBTQ+ teens.

NRx will submit existing data on the safety and efficacy of ketamine for adults in support of its NDA. Following FDA guidance, NRx and HOPE Therapeutics will conduct a clinical trial for adolescents without the requirement to study younger age groups initially. Additional neurotoxicity studies in juvenile animals will support the safety profile of intravenous ketamine for this younger demographic.

NRx Pharmaceuticals focuses on therapeutics for central nervous system disorders, including suicidal bipolar depression, chronic pain and PTSD. The company is developing NRX-101, a Breakthrough Therapy-designated treatment for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for NRX-100 (IV ketamine) based on extensive clinical trial data and newly licensed data from French health authorities, underlining its Fast Track Designation from the FDA for acute suicidality treatment protocols.

HOPE Therapeutics operates a network of clinics providing ketamine and other therapies for suicidal depression, supported by a digital platform to enhance and maintain NMDA-targeted drug therapy benefits.