According to Nasus Pharma, a stability study of the company’s FMXIN002 nasal epinephrine powder demonstrated full stability for the formulation and device over 5 years of storage at 15 to 25℃. The company said that at 5 years, the epinephrine level was at 97.5%, with degradation products at 0.37%. Nasus noted that a previous stability test at 40℃ and 75% humidity demonstrated full stability at 6 months.
Nasus is developing FMXIN002 for the treatment of anaphylaxis and has previously reported positive PK data for the nasal powder compared to EpiPen. The company points out that solution formulations of epinephrine require the use of stabilizers and have expiration dates that range from 12 to 18 months.
Nasus CEO Dalia Megiddo commented, “The results of our long-term stability study as well as the results from our Phase 2 clinical study are further confirmation of the advantages of our proprietary powder intranasal epinephrine FMXIN002 in offering [an] easy-to-use, reliable small device that can be carried around in a small pocket and is a highly effective immediate treatment for anaphylactic shock.”
Executive Chairman of the Board Udi Gilboa said, “We are extremely encouraged by the data generated by the company up until today including the latest outstanding results showing unheard of epinephrine stability of 5 years. The commercial potential of our powder-based epinephrine product and its potential to become the fastest-acting, simple-to-administer, needle-free nasal spray, provides patients and caregivers with the most promising alternative for this growing Type 1 allergic reaction market. . . . 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.”
Read the Nasus Pharma press release.
