Nasus Powder Epinephrine offers long term stability as well as rapid and higher epinephrine absorption- changing the face of anaphylactic shock treatment TEL AVIV, Israel , Aug. 6, 2024 /PRNewswire/ -- Nasus Pharma Ltd , a clinical-stage biopharmaceutical company focused on developing needle-free, powder-based Intranasal (PBI) product portfolio, to address acute medical conditions announced the results of a 5 years stability study of its FMXIN002 drug candidate – nasal powder epinephrine for the treatment of severe allergy and anaphylactic shock. FMXIN002 is an investigational intranasal epinephrine powder spray device that is noninvasive, needle-free, user-friendly, and reliable and could provide timely effective rescue for severe potentially life-threatening allergic reactions to food, medications, and insect bites.
FMXIN002 stored 5-year at room temperature (15-25° Celsius) showed full stability of the nasal powder and device. Epinephrine base was 97.5% at 5 years well within the defined limits (95-105% ICHQ1).
The levels of degradation products were 0.37% which is significantly below the maximum level of 4 % defined for the low-dose (<10 mg) producta. In addition, the enantiomeric purity was found to be 100%,.
These results are in line with prior results of FMXIN002 showing full stability after 6 months in accelerated conditions (40° Celsius and 75% humidity). These findings are also in line with a prior study that compared FMXIN002 with Epipen autoinjectors showing 1.