Phase 2 Data Show NS002 Intranasal Epinephrine Acts Faster Than EpiPen

Preliminary results from a phase 2 clinical study suggest that NS002, an investigational intranasal epinephrine powder developed by Nasus Pharma, may offer rapid and robust epinephrine exposure compared with standard intramuscular autoinjector therapy.1 The findings, announced on January 20, 2026, showed that NS002 achieved faster absorption and higher peak plasma concentrations, potentially addressing a critical clinical need in the management of anaphylaxis.

“We believe these interim results are highly encouraging and reinforce the potential of NS002 as a meaningful advancement in anaphylaxis treatment," said Michael Blaiss, MD, clinical professor of allergy and immunology at the Medical College of Georgia at Augusta University and member of Nasus Pharma's Scientific Advisory Board, in a statement.1 “In anaphylaxis, outcomes are highly time-dependent, and delays in achieving effective pharmacologic action are associated with increased mortality. These pharmacokinetic advantages, combined with the needle-free administration, could help address the significant compliance challenges we see with current treatments."

In this open-label, healthy volunteer study, NS002 demonstrated a mean peak plasma concentration (Cmax) of 655 pg/mL versus 548 pg/mL with EpiPen, with time to peak concentration (Tmax) occurring at 10.8 minutes compared to 15 minutes for the autoinjector. Additionally, 91% of participants administered NS002 surpassed the therapeutic plasma threshold of 100 pg/mL within 5 minutes, compared with 67% with EpiPen. Early exposure, measured by area under the concentration-time curve (AUC) over the first 10 minutes, was also greater for NS002 (55 hpg/mL vs 32 hpg/mL), underscoring its potential for quicker pharmacologic action during acute allergic emergencies.1

The study enrolled 50 healthy adults with allergic rhinitis across 2 cohorts to assess single and repeat dosing with and without a nasal allergic challenge, simulating real-world anaphylactic conditions. NS002 was well-tolerated with no serious adverse events, and the pharmacodynamic responses (blood pressure, pulse rate) were comparable to the intramuscular standard of care.1

These interim results align with published data suggesting powder-based intranasal epinephrine formulations can improve early drug absorption and stability compared with liquid autoinjectors. Prior research involving a smaller cohort demonstrated similar rapid attainment of therapeutic plasma levels with NS002 and highlighted its potential as a needle-free, patient-friendly alternative to traditional epinephrine delivery.2

The development of needle-free epinephrine alternatives comes amid broader innovation in anaphylaxis management. For example, ARS Pharmaceuticals’ epinephrine nasal spray (neffy) received expanded FDA approval in 2025 for use in younger pediatric patients (15–30 kg), reflecting growing interest in non-injectable epinephrine delivery systems.3

Anaphylaxis remains a rapidly progressive, potentially fatal type I hypersensitivity reaction in which prompt administration of epinephrine can be lifesaving. Clinicians recognize that treatment delays, hesitation due to needle phobia, and device complexity are barriers to optimal care—challenges that intranasal approaches aim to mitigate.4

"We are extremely pleased with these positive interim results, which we believe further validate NS002's potential as a first-in-class intranasal powder epinephrine product for patients with severe allergies," said Dan Teleman, chief executive officer of Nasus Pharma, in a statement.1 "The sustained performance of NS002 across single and repeat dosing scenarios – including under conditions simulating real-world allergic reactions – demonstrates the robustness of our proprietary Nasax® platform technology. We look forward to completing the Phase 2 study and advancing to our pivotal clinical program."

Nasus Pharma plans to complete the full Phase 2 analysis by late Q1 2026 and to initiate a pivotal study in Q4 2026.1

References

1. Nasus Pharma, Ltd. Nasus Pharma Announces Positive Interim Results from Phase 2 Clinical Study of NS002 Intranasal Epinephrine Powder. GlobeNewswire News Room. Published January 20, 2026. Accessed January 20, 2026. https://www.globenewswire.com/news-release/2026/01/20/3221623/0/en/Nasus-Pharma-Announces-Positive-Interim-Results-from-Phase-2-Clinical-Study-of-NS002-Intranasal-Epinephrine-Powder.html

2. Nasus Pharma. Nasus Pharma Announces Publication Of Its Positive Clinical Results With FMXIN002 Intranasal Powder Epinephrine Spray In The Journal Of Allergy And Clinical Immunology In Practice. Prnewswire.com. Published August 8, 2023. Accessed January 20, 2026. https://www.prnewswire.com/news-releases/nasus-pharma-announces-publication-of-its-positive-clinical-results-with-fmxin002-intranasal-powder-epinephrine-spray-in-the-journal-of-allergy-and-clinical-immunology-in-practice-301895372.html?utm_source=chatgpt.com

3. Campbell P. FDA Approves 1 mg neffy Nasal Spray for Pediatric Anaphylaxis. Hcplive.com. Published March 6, 2025. Accessed January 20, 2026. https://www.hcplive.com/view/fda-approves-1-mg-neffy-nasal-spray-for-pediatric-anaphylaxis

4. Greenhawt M, Schroer B, Kraft C, et al. One Year Later: How Intranasal Epinephrine Is Changing Emergency Allergy Treatment. Hcplive.com. Published August 8, 2025. https://www.hcplive.com/view/one-year-later-how-intranasal-epinephrine-is-changing-emergency-allergy-treatment