Nasus Pharma (NSRX) Study result summary

Study design and objectives

• Phase II open-label study evaluated NS002, an intranasal epinephrine powder, in 50 healthy adults with allergic rhinitis, simulating real-world scenarios including nasal congestion and repeat dosing.

• Subjects received both NS002 and EpiPen under normal and allergen-challenged conditions, with comprehensive pharmacokinetic, pharmacodynamic, and safety assessments.

• Study incorporated FDA feedback and compared single vs. repeat dosing, including administration in same or contralateral nostril.

• Study aimed to assess speed, absorption, and safety of NS002 versus EpiPen® in real-world scenarios.

Key efficacy and pharmacokinetic results

• NS002 achieved a median T100 (time to therapeutic threshold) of 1.69 minutes, twice as fast as EpiPen's 3.42 minutes (p=0.033).

• At 2.5 minutes, 67% of NS002 subjects reached threshold vs. 27% for EpiPen; at 5 minutes, 88% vs. 64%.

• NS002 reached peak concentration in 15 minutes vs. 19.8 minutes for EpiPen®.

• In the first 10 minutes, NS002 delivered 60% higher total epinephrine absorption compared to EpiPen.

• NS002 maintained therapeutic epinephrine levels even under nasal congestion, with higher and faster absorption than EpiPen.

Safety and tolerability

• NS002 was well-tolerated with no serious adverse events; most adverse events were mild, local, and self-resolving.

• Pharmacodynamic effects (blood pressure, heart rate) tracked with EpiPen and remained within normal physiological limits.

• Minimal nasal irritation observed, supporting favorable tolerability profile.