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Nasus Pharma Announces Positive Top Line Data from Phase 2 Clinical Study of NS002: Achieves Significantly Superior and Faster Epinephrine Delivery Compared to EpiPen® with Accelerated Speed to Therapeutic Threshold
Globenewswire· 2026-03-16 11:30
Core Insights - Nasus Pharma's NS002 demonstrated significantly faster absorption of epinephrine compared to EpiPen®, achieving the critical 100 pg/mL threshold in a median of 1.69 minutes versus 3.42 minutes [1][2][5] - The company plans to initiate a pivotal clinical study for NS002 in the fourth quarter of 2026 [2][4] Group 1: Clinical Study Results - The Phase 2 study enrolled 50 healthy adults, showing NS002's advantages in various administration scenarios during anaphylactic emergencies [3] - At 2.5 minutes, 67.4% of NS002 participants reached the therapeutic threshold compared to 27.1% with EpiPen® [5] - By 10 minutes, approximately 95% of NS002 participants reached the therapeutic threshold, indicating superior performance [5] Group 2: Pharmacokinetic and Pharmacodynamic Advantages - NS002 reached peak concentration in a median of 15 minutes, faster than EpiPen®'s 19.8 minutes [5] - Total epinephrine absorption in the critical 10-minute window was about 50% higher with NS002 compared to EpiPen® [5] - Repeat doses of NS002 maintained pharmacokinetic advantages, crucial for patients needing additional doses during severe anaphylaxis [5][6] Group 3: Safety Profile - NS002 exhibited a favorable safety and tolerability profile, with no serious adverse events reported [6] - The study results suggest NS002 could outperform EpiPen® in real-world conditions, including challenging scenarios [6] Group 4: Company Overview - Nasus Pharma is focused on developing innovative intranasal products, with NS002 as a needle-free alternative for anaphylaxis treatment [8] - The proprietary Nasax® powder platform is designed for rapid and reliable drug delivery, leveraging the nasal cavity's vascular network [8]