Nasus Pharma Reveals Five-Year Stability of FMXIN002 Nasal Epinephrine Powder for Severe Allergy and Anaphylaxis

TEL AVIV, Israel, Aug. 6, 2024 – Nasus Pharma Ltd, a clinical-stage biopharmaceutical company specializing in needle-free, powder-based intranasal (PBI) products for acute medical conditions, has announced promising results from a five-year stability study of its FMXIN002 drug candidate—nasal powder epinephrine for severe allergies and anaphylactic shock.

FMXIN002 is an investigational intranasal epinephrine powder spray device designed to be noninvasive, user-friendly, and dependable. It aims to provide effective and timely rescue for severe allergic reactions to food, medications, and insect stings. The product demonstrated complete stability when stored at room temperature (15-25° Celsius) for five years, maintaining 97.5% of its epinephrine base, which is comfortably within the 95-105% ICHQ1 defined limits. Degradation products were minimal, just 0.37%, far below the 4% maximum for low-dose products. The enantiomeric purity of the drug was 100%, confirming earlier results under accelerated conditions (40° Celsius and 75% humidity). These stability findings surpass those of Epipen autoinjectors, which showed higher levels of S-Epinephrine impurities.

Epinephrine, the core treatment for severe allergies and anaphylaxis, is notoriously unstable in liquid form, necessitating multiple stabilizers that come with their own safety concerns. Liquid epinephrine typically has an expiration date between 12-18 months. FMXIN002, however, is a proprietary powder formulation requiring no stabilizers and boasting a significantly longer stability period. 

The long-term stability of FMXIN002 offers substantial benefits for both patients and healthcare payors. Patients currently need to replace their autoinjectors roughly every 12 months, which is costly. Moreover, the stability of FMXIN002 under extreme heat and humidity conditions means users can carry the inhaler during daily activities without worrying about environmental factors compromising its efficacy.

Nasus Pharma recently published the results of a phase 2 clinical study highlighting the advantages of FMXIN002 in achieving quicker and higher levels of epinephrine in the bloodstream compared to Epipen autoinjectors, particularly in the critical first 30 minutes after anaphylaxis onset. The powder-based intranasal epinephrine showed a superior pharmacokinetic profile, with 91% of patients reaching the clinical threshold of epinephrine in just six minutes, addressing medical community concerns about the adequacy of solution-based nasal epinephrine products.

Dr. Dalia Megiddo, CEO of Nasus Pharma, stated, "The results of our long-term stability study, along with our phase 2 clinical study, confirm the advantages of our proprietary intranasal epinephrine powder FMXIN002. It offers a reliable, easy-to-use device that is highly effective for immediate anaphylactic shock treatment." 

Udi Gilboa, Executive Chairman of Nasus Pharma, added, "We are very encouraged by the data we've generated, demonstrating an unprecedented five-year stability for our epinephrine product. The commercial potential of FMXIN002 as a needle-free, fast-acting nasal spray is immense. This product offers a promising alternative in the growing market for Type I allergic reaction treatments, presenting financial advantages due to its extended stability compared to the 12-18 months of liquid epinephrine solutions."

FMXIN002 is a powder formulation of epinephrine designed for nasal delivery, based on Nasus Pharma's proprietary technology. It is expected to allow individuals to administer epinephrine easily and quickly in emergencies without the hesitation associated with current auto-injectors. The device, using APTAR Nasal Unidose Powder technology, features intuitive one-dose nasal drug delivery and 360° functionality.

Anaphylaxis is a severe, life-threatening allergic reaction that can occur suddenly and can be fatal if not treated promptly. In the U.S. alone, around 5 million people are at risk, with over 200,000 emergency room visits due to severe food allergies reported annually.

Nasus Pharma is also developing other intranasal powder products using its unique microsphere technology, aimed at addressing acute emergency situations like opioid overdose and anaphylactic shock. Their portfolio includes completed pivotal studies on intranasal naloxone and phase 2 studies on intranasal epinephrine, alongside several preclinical proof-of-concept programs.

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