Needle-Free Powder Epinephrine Nasal Spray Shows Positive Results in Clinical Study


Rapid and higher epinephrine absorption – for potentially quicker rescue of patients in anaphylactic shock

TEL AVIV, Israel, Aug. 8, 2023 /PRNewswire/ — Nasus Pharma Ltda clinical-stage biopharmaceutical company focused on developing needle-free, powder-based Intranasal (PBI) product portfolio, to address acute medical conditions announced the publication of positive results from a clinical study of intranasal powder-based Epinephrine.

FMXIN002 is an investigational intranasal epinephrine powder spray device that is noninvasive, user-friendly and reliable and could provide timely effective rescue for severe potentially life-threatening allergic reactions to food, medications and insect bites. The clinical study provides additional compelling evidence to the robustness of Nasus Pharma’s intranasal powder technology already tested in other drugs. Importantly the pharmacokinetics of the powder-based intranasal epinephrine can potentially abate multiple concerns recently raised within the medical community as to the adequacy of other intranasal solution-based epinephrine with regards to protection in the immediate period following anaphylactic shock development.

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“The results of Nasus’s FMXIN002 powder intranasal epinephrine study show that it can provide a safer and more effective rescue for the emergency treatment of life-threatening allergic reactions by providing a compact easy-to-use device and quicker absorption of Epinephrine,” said Dr. Dalia Megiddo. Nasus Pharma CEO. “The publication of our results in a prominent scientific journal such as JACI: In Practice will ensure the dissemination of FMXIN002’s promise within the relevant medical community.”

The FMXIN002 clinical study was an open-label, ascending dose, two-period, three-treatment, comparative bioavailability study designed to compare the PK profile of FMXIN002 with the current standard of care- an intramuscular epinephrine autoinjector. (EpiPen® , Mylan )

Twelve (12) volunteers with known seasonal allergies received three-sequenced treatment with either 0.3 mg IM epinephrine via an autoinjector or FMXIN002 in dosages of 1.6 and 3.2 mg. Each intranasal dosage was tested under normal conditions and under nasal allergen challenge in which nasal congestion was created to simulate the congestion of the nose in anaphylaxis. The results demonstrate that the exposure (AUC0-t) and maximum plasma level (Cmax) of a 3.2 mg FMXIN002 dose was comparable to a 0.3 mg IM injection of epinephrine under normal nasal conditions. Moreover FMXIN002 showed a significantly superior PK profile especially during the first 30 minutes under induced nasal congestions that occurs in severe allergic reactions: Cmax was double, compared to IM autoinjector (1110 vs. 551). AUC (0-8h ) was 56% higher (672 vs. 431). The time to maximum plasma level (Tmax) and time to 100 pg/mL of a 3.2 mg FMXIM001 dose was significantly faster than IM injection. Median T max for IM injection was 9.0 minutes compared to 2.5 minutes for 3.2 mg FMXIN002 under nasal congestion conditions. Median Time to 100 pg/mL was 3.0 minutes under normal conditions and 1.0 minutes under allergenic challenge that represents the real-life conditions of the nose in severe allergic reaction for FMXIN002. The time to 100 pg/mL is considered to be the clinical threshold where pharmacodynamic responses begins to occur. These findings indicate that FMXIN002 can provide an unprecedented quick rescue with a non-invasive easy to use device for life threatening allergic reactions.

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The treatment was well tolerated. There were no significant side effects and no significant  changes physiological parameters. Prof Yuval Tal MD PhD, Director of Allergy and Clinical Immunology unit at Hadassah Medical Center who headed the study added:

“In cases of severe life-threatening allergic reaction the therapeutic time window is very short and immediate rescue with epinephrine is required. Therefore, the pharmacokinetics/pharmacodynamics of epinephrine rescue are extremely important. Failure to administer epinephrine promptly has been identified as the most important factor contributing to death from anaphylaxis. Parents and care givers are often hesitant to give injections. Teenagers are averse to carry the bulky two injection package with them at all times and are sadly over-represented in fatality cases. A pocket-size user-friendly nasal inhaler could make the much-needed difference sorely needed for rescue therapy of life-threatening allergic reactions. This, in addition to the significantly shorter time to therapeutic blood levels and higher drug exposure in the critical first half an hour indicate that FMXIN002 could change dramatically the fatality risk associated with anaphylaxis.”

This pilot study indicates that powder-based intranasal epinephrine can offer significant clinical advantages, as compared to the currently-available intramuscular route of drug administration and other solution-based intranasal epinephrine programs in development. Powder-based products are also known to have better stability, as compared to the solution-based products. Yet an additional advantage for powder-based formulation of epinephrine, a drug that undergoes rapid degradation in the currently-available short shelf-life liquid dosage forms.

About FMXIN002

FMXIN002 is a powder formulation of epinephrine nasal spray developed by Nasus Pharma based on its unique intranasal powder proprietary technology. The company believes that the FMXIN002 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 auto-injectors. FMXIN002 uses APTAR Nasal Unidose Powder 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 Some 5 million people in the United States are at risk of having an anaphylaxis reaction. Over 200,000 emergency room visits due to severe reactions from food allergies are reported annually.

About Nasus Pharma

Based on its unique microsphere technology, Nasus Pharma is developing a number of intranasal powder products aimed at assisting patients in several acute emergency situations such as opioid overdose and anaphylactic shock.

Intranasal administration is most suitable for those situations in which rapid drug delivery is required and offers multiple advantages such as rapid drug delivery, ease of use, non-invasiveness, and safety. Nasus portfolio comprises a number of programs: Intranasal Naloxone completed pivotal study and Intranasal Epinephrine (phase 2) as well as a number of preclinical POC programs.

Nasus Pharma Ltd. Israel

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