Nasus Pharma Reveals Promising Phase 2 Study Results for FMXIN002, a Novel Intranasal Epinephrine Powder

Nasus Pharma's Groundbreaking Results in Allergy Treatment

Nasus Pharma Ltd., a biopharmaceutical company specializing in innovative medical solutions, has recently published positive results from its Phase 2 clinical study on FMXIN002, an intranasal epinephrine powder. This product aims to provide a needle-free alternative for individuals experiencing severe allergies and anaphylactic reactions.

The clinical trial took place at Hadassah Medical Center and was documented in the prestigious Journal of Allergy and Clinical Immunology. It assessed the efficacy and safety of FMXIN002 compared to the traditional intramuscular EpiPen. The trial involved healthy volunteers who received different dosages of the powder, namely 3.6 mg and 4 mg, to analyze their absorption rates in the bloodstream in contrast to the standard 0.3 mg EpiPen.

Key Findings of the Study

The results demonstrated a significant advantage for the FMXIN002 4.0 mg dosage. Notably, 91% of participants achieved therapeutic plasma epinephrine levels within just six minutes, a stark contrast to only 55% for the IM EpiPen. The data suggested a much higher absorption rate as well; the area under the absorption curve for FMXIN002 was significantly elevated compared to the EpiPen, measuring 7.49 h/pg/mL against 2.06 h/pg/mL, with a statistical significance (P= 0.0377).

Moreover, all treatments showed similar safety profiles, with no severe adverse events reported. The study confirmed that FMXIN002 remains stable under various conditions, with a remarkable shelf life of up to five years.

Expert Endorsement

Professor Yuval Tal, who oversees the Allergy and Clinical Immunology Clinic at Hadassah, expressed optimism regarding FMXIN002’s potential for transforming emergency treatment for anaphylaxis. “This study indicates that our intranasal epinephrine powder may allow for quicker and more significant absorption of epinephrine during critical therapeutic periods,” he remarked.

He further highlighted the challenges associated with traditional autoinjectors, such as needle shyness and the inconvenience of frequent replacements, emphasizing that FMXIN002 could provide a more accessible, user-friendly, and portable solution for individuals at risk of severe allergic reactions.

Overview of FMXIN002 (NS002)

FMXIN002, also referred to as NS002, utilizes Nasus Pharma's proprietary intranasal powder technology. The product targets the urgent need for fast-acting treatments during allergic emergencies, enabling patients to administer epinephrine with ease and confidence.

The formulation leverages a specialized nasal powder delivery device from Aptar Pharma that is designed for intuitive use and can effectively deliver medication in critical moments.

Anaphylaxis, characterized by rapid onset and life-threatening conditions requiring immediate treatment, affects millions. In the U.S., roughly 40 million people suffer from type 1 allergies, with 20 million at risk of severe reactions.

About Nasus Pharma

Nasus Pharma is at the forefront of developing intranasal powders that address acute community emergencies, including anaphylactic shock and opioid overdose. Their approach prioritizes rapid drug delivery while ensuring user safety and non-invasiveness. The company is advancing various products through different developmental phases, paving the way for innovative healthcare solutions.

In conclusion, this recent study marks a crucial step towards enhancing the way severe allergies are managed and treated, pointing to brighter futures for patients who rely on effective and timely interventions. Nasus Pharma's groundbreaking work promises to not only improve medical accessibility but also change lives through medical innovation.