Nasus Pharma Announces Positive Interim Results from Phase 2 Clinical Study of NS002 Intranasal Epinephrine Powder

Core Insights - Nasus Pharma's NS002 shows significantly faster absorption and higher peak epinephrine levels compared to EpiPen, with 91% of participants achieving the 100 pg/ml plasma threshold at 5 minutes versus 67% for EpiPen [1][3] - The interim results indicate that NS002 is well-tolerated with no serious adverse events reported, and the pharmacodynamic response is comparable to EpiPen [1][5] - Full Phase 2 results are expected by the end of Q1 2026, with a pivotal study initiation planned for Q4 2026 [1][7] Study Design - The open-label Phase 2 study enrolled 50 healthy adults with a history of allergic rhinitis, divided into two cohorts [2] - The first cohort of 25 participants received NS002 or EpiPen with and without a nasal allergic challenge, while the second cohort received repeat doses under similar conditions [2] Key Interim Results - NS002 achieved a mean peak plasma concentration (Cmax) of 655 pg/ml compared to 548 pg/ml for EpiPen, with a peak concentration (Tmax) reached in 10.8 minutes versus 15 minutes for EpiPen [3] - Total epinephrine absorption in the critical 10-minute window was higher for NS002 (AUC: 55 hpg/ml) compared to EpiPen (AUC: 32 hpg/ml) [3] Safety and Tolerability - NS002 was well-tolerated, with 95% of treatment-emergent adverse events being mild and self-resolving, primarily local [5] - The pharmacodynamic response, including changes in blood pressure and pulse rate, remained within normal ranges and was comparable to EpiPen [5] Expert Commentary - Clinical experts highlight the potential of NS002 as a significant advancement in anaphylaxis treatment due to its faster delivery and higher concentrations of epinephrine [6] - The needle-free administration of NS002 could address compliance challenges associated with current treatments [6] Future Plans - Nasus Pharma aims to complete the Phase 2 study by the end of Q1 2026 and plans to initiate its pivotal clinical study in Q4 2026 [7]