NRx Pharmaceuticals is advancing towards New Drug Application (NDA) filings for two key drug candidates, NRX-100 (IV Ketamine) and NRX-101 (oral D-cycloserine/lurasidone), targeting suicidal ideation in depression and bipolar depression, respectively. The company anticipates filing these NDAs by the end of 2024, with a PDUFA date forecast for 2025. This strategic move aims to address the critical unmet need for effective and safe treatments for acute suicidality and treatment-resistant bipolar depression.
NRX-100: Addressing Acute Suicidality with IV Ketamine
NRX-100, an intravenous ketamine formulation, has demonstrated a highly significant reduction in suicidal ideation compared to placebo and active comparators across multiple clinical trials involving over 500 patients. Data also suggest that IV ketamine may be superior to electroshock therapy in treating depression, based on post-hoc analysis. NRx Pharmaceuticals has completed stability and toxicology data requirements and has aligned with the FDA on its Pediatric Study Plan, paving the way for NDA submission. If approved, NRX-100 could become the first FDA-labeled medicine for acute suicidality, a condition responsible for one American life lost every 11 minutes, according to the CDC.
NRX-101: A Novel Approach to Bipolar Depression with Suicidality
NRX-101, a combination of D-cycloserine and lurasidone, is being developed for accelerated approval in bipolar depression with suicidality or akathisia. Phase 2b/3 trial data showed depression efficacy comparable to the standard of care and a statistically significant reduction in akathisia (P=0.025) and time to sustained remission from suicidality (P=0.05). These findings, along with data from the STABIL-B trial, support NRX-101's potential as a best-in-class medication for this multi-billion-dollar market in the US. Akathisia, a side effect of many antidepressants, is closely linked to increased suicide risk, making NRX-101 a potentially safer option for this vulnerable patient population.
HOPE Therapeutics: Building a Network for Suicide Prevention
NRx Pharmaceuticals' wholly-owned subsidiary, HOPE Therapeutics, is actively building a network of Interventional Psychiatry Clinics through strategic acquisitions. These clinics will offer a range of therapies, including ketamine and Transcranial Magnetic Stimulation (TMS), to patients with suicidal depression and PTSD. HOPE Therapeutics expects to generate its first revenues by the end of 2024 and is projected to be profitable in 2025.
Financial Highlights and Future Outlook
NRx Pharmaceuticals has significantly reduced its net operating losses, reporting a 74% decrease in Q3 2024 compared to Q3 2023. This improvement is attributed to reduced research and development expenses and efficient cash management. The company secured $10.8 million in convertible-debt funding to support the NDA filings for NRX-100 and NRX-101 and to retire prior debt. NRx Pharmaceuticals forecasts first corporate revenues by year-end 2024 and profitability in 2025, driven by HOPE Therapeutics and medication sales.
