Nasus Pharma said that in a second PK study of FMXIN002 intranasal dry powder epinephrine, 91% of subjects who received a 4 mg dose of the nasal formulation reached the clinical threshold for plasma exposure at 6 minutes post dose compared to 51% who received a dose of epinephrine from an EpiPen. The company reported results from the initial PK study in June 2021. FMXIN002 is delivered via Aptar Pharma‘s Unidose nasal powder delivery device.
As in the first PK study, the NP-006-Epinephrine study enrolled 12 healthy volunteers and compared 2 dose levels of FMXIN002 to EpiPen. The dose levels evaluated in the first study were 1.6 and 3.2 mg; the new study evaluated doses of 3.6 and 4 mg.
Nasus Pharma CEO Dalia Megiddo commented, “The results of NP-006-Epinephrine study are further confirmation of the advantages of our powder intranasal epinephrine in covering the immediate period of anaphylactic shock, both in creating higher levels of epinephrine in the blood quicker and in creating clinically meaningful epinephrine levels in significantly more patients. FMXIN002 can potentially be more effective rescue for the emergency treatment of life-threatening allergic reactions by providing a compact easy-to-use, needle-free device and quicker absorption of epinephrine.”
Executive Chairman of the Board Udi Gilboa said, “We are extremely encouraged by the data generated by the company up until today including in this dose response Phase 2 trial. 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. . . . 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.”
Read the Nasus Pharma press release.
