Nasus Pharma Publishes Positive Phase 2 Results for Intranasal NS002

Nasus Pharma Publishes Positive Phase 2 Results for Intranasal NS002

By, Admin 4 June 2025

TEL AVIV, ISRAEL – June 4, 2025 — Nasus Pharma Ltd., a clinical-stage biopharmaceutical company focused on needle-free, powder-based intranasal (PBI) products for emergency medicine, today announced the peer-reviewed publication of results from its Phase 2 clinical trial of NS002 (FMXIN002), an intranasal epinephrine powder spray for the treatment of anaphylaxis and severe Type 1 allergic reactions.

The study was published in The Journal of Allergy and Clinical Immunology: Global (J Allergy Clin Immunol Global 2025;4:100487) and was conducted at the Clinical Research Unit of Hadassah Medical Center, Israel.

Study Highlights

This open-label, randomized, crossover trial enrolled 12 healthy volunteers to assess the bioequivalence of two doses of NS002 (3.6 mg and 4.0 mg) compared with the standard 0.3 mg intramuscular (IM) epinephrine autoinjector (EpiPen®).

Key findings:

  • Faster and higher absorption was observed with NS002 4.0 mg:
    • 91% of participants reached the clinical plasma threshold (≥100 pg/mL) within 6 minutes, compared to 55% in the IM group.
    • Early exposure (AUC₀–₄min) was significantly higher for NS002 (7.49 h·pg/mL vs. 2.06 h·pg/mL; P = 0.0377).
  • Pharmacodynamic responses and safety profiles were comparable across all arms.
  • No serious adverse events were reported; all mild events resolved spontaneously.
  • NS002 exhibited robust stability, including 5-year shelf life at room temperature.

Clinical Significance

“This study demonstrates that FMXIN002 (NS002) intranasal epinephrine powder could enable faster and higher absorption of epinephrine during the short therapeutic window required for the treatment of anaphylaxis. Its needle-free, user-friendly formulation and extended shelf life could revolutionize emergency treatment, improving access and adherence potentially saving lives.”

  • Prof. Yuval Tal, Head of Allergy and Clinical Immunology Clinic, Hadassah Medical Center.

About FMXIN002 (NS002)

FMXIN002 (NS002) is a dry powder intranasal epinephrine product, based on Nasus Pharma’s proprietary powder delivery platform and formulated using Aptar Pharma’s Unidose device, offering:

  • Needle-free administration
  • Rapid systemic absorption
  • Compact, intuitive design
  • 360° usability
  • Long-term room temperature stability

The product is designed to address barriers associated with traditional IM autoinjectors — such as needle phobia, limited shelf life, portability challenges, and cost/access barriers, particularly in resource-limited settings.

Unmet Need in Anaphylaxis Management

Anaphylaxis is a rapid-onset, life-threatening allergic reaction that requires immediate intervention. Despite the availability of autoinjectors:

  • Many patients delay or avoid use due to fear or unfamiliarity.
  • Access remains limited in several global regions.
  • Frequent expiration and replacement costs reduce adherence.

There are an estimated 40 million patients with type 1 allergies in the U.S., of whom around 20 million are at risk for anaphylaxis.

About Nasus Pharma Ltd.

Nasus Pharma is a clinical-stage biopharmaceutical company leveraging its microsphere powder-based intranasal technology to develop treatments for acute medical emergencies. Its pipeline includes candidates for:

  • Anaphylaxis (NS002)
  • Opioid overdose
  • Other acute indications where rapid, non-invasive intervention is critical.

Nasus Pharma's products are designed for community-based use, emphasizing portability, ease of use, and broad accessibility.

Forward-Looking Statement

This press release contains forward-looking statements regarding the development and potential impact of NS002. These statements reflect the current views of Nasus Pharma management and are subject to risks and uncertainties that may cause actual results to differ materially. The Company does not undertake any obligation to update these statements, except as required by law.

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