Nasus Pharma Announces the Publication of Positive Clinical Results from its Phase 2 Study of FMXIN002 (NS002) Intranasal Epinephrine Powder
TEL AVIV, Israel, June 3, 2025 /PRNewswire/ -- Nasus Pharma Ltd. ("Nasus Pharma" or the "Company"), a clinical-stage biopharmaceutical company focused on developing needle-free, powder-based intranasal ("PBI") products addressing acute, community based, medical emergencies, today announced the publication of its phase 2 NS002 clinical study performed at the Clinical Research Unit of Hadassah Medical Center in The Journal of Allergy and Clinical Immunology (Global). NS002 is an Epinephrine powder nasal spray for the treatment of type 1 severe allergies and anaphylaxis.
The published article (J Allergy Clin Immunol Global 2025;4:100487) explored the comparative bioequivalence of different dosages of intranasal powder Epinephrine (3.6 and 4 mg) compared to the current standard of care, 0.3 mg EpiPen (Epinephrine intramuscular ("IM") autoinjector). This was an open-label, single-dose, 3-treatment, crossover, randomized study that included 12 healthy volunteers.
The study results demonstrated that FMXIN002 (NS002) 4.0 mg had faster and higher absorption by all participants, compared to the IM autoinjector: 91% of subjects achieved the hemodynamic clinical threshold of 100 pg/mL plasma Epinephrine at 6 minutes after administration of FMXIN002(NS002) 4.0 mg compared to 55% of subjects receiving the IM autoinjector. The absorption area under the curve for the first 4 minutes was significantly higher for NS002 4.0 mg (geometric mean: 7.49 h/pg/mL vs 2.06 h/pg/mL, respectively; P= 0.0377). The pharmacodynamic response and safety were comparable among all treatments. No serious adverse events occurred, all events were mild and self-resolved. FMXIN002(NS002) was highly stable at all tested conditions including 5 years at room temperature.
Prof. Yuval Tal, Head of Allergy and Clinical Immunology Clinic at Hadassah Medical Center commented:
"This study demonstrates that FMXIN002 (NS002) intranasal Epinephrine powder could enable faster and higher absorption of Epinephrine into the plasma during the short therapeutic window required for the treatment of anaphylaxis. I have followed the development of NS002 since its first in-human study and am excited about its potential as a simple, convenient, needle free alternative to IM Epinephrine. Intranasal Epinephrine dry powder represents a transformative advancement in anaphylaxis treatment. Unlike traditional autoinjectors - which are unavailable in many countries, require frequent replacement and often deter use due to needle phobia - this needle-free, compact, and user-friendly formulation could potentially offer in the future an alternative with a shelf life exceeding five years. Its design could facilitate easy and rapid administration, and its portability could allow individuals to carry multiple doses effortlessly. By addressing the limitations of current treatments, this innovation could have the potential to significantly improve accessibility and adherence, ultimately saving lives in emergency situations."
About FMXIN002 (NS002)
FMXIN002, also known as NS002, is a powder formulation of Epinephrine nasal spray developed by Nasus Pharma based on its unique intranasal powder proprietary technology. The Company believes that FMXIN002 (NS002) may enable people to deliver Epinephrine in emergency situations easily, rapidly, and with less hesitation, at the onset of an allergic reaction, as compared to currently available Epinephrine autoinjectors. FMXIN002 uses Aptar Pharma's Unidose nasal powder unit dose spray device – an intuitive and easy-to-use device with 360° functionality and precise one-dose nasal drug delivery.
Anaphylaxis is a severe, life-threatening allergic reaction with a sudden onset that can occur within a few minutes, and unless treated promptly, could be fatal. There are approximately 40 million patients with type 1 allergies in the United States alone, of which approximately 20 million patients who experience severe type 1 allergic reactions that may lead to anaphylaxis.
About Nasus Pharma Ltd.
Based on its unique microsphere technology, Nasus Pharma is developing a number of intranasal powder products addressing acute emergency situations in the community such as anaphylactic shock and opioid overdose.
Intranasal administration is most suitable for those situations in which rapid treatment is required and could offer multiple advantages such as rapid drug delivery, ease of use, non-invasiveness, and safety. Nasus Pharma's portfolio comprises a number of programs in different stages of development.
Forward Looking Statements
This press release contains express or implied forward-looking statements. For example, the Company is using forward-looking statements when it discusses FMXIN002 (NS002) its development and potential benefits. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as otherwise required by law, the Company undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Contact: Info@nasuspharma.com Nasus Pharma Ltd. Israelhttps://www.nasuspharma.com
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