Nasus Pharma said that a Phase 1 PK study of its FMXIN002 intranasal dry powder epinephrine demonstrated that FMXIN002 could produce a maximum plasma level comparable to that of epinephrine delivered via EpiPen and reached that level significantly faster than the injection. The open-label SAD study enrolled 12 volunteers and compared 1.6 and 3.2 mg doses of FMXIN002 to a 0.3 mg dose of intramuscular epinephrine under both usual conditions and nasal allergen challenge.
According to Nasus, during the first 30 minutes of the nasal allergen challenge, the Cmax for the 3.2 mg dose of FMXIN002 was twice that of the autoinjector, and Tmax was 2 minutes compared to 19.8 minutes for intramuscular epinephrine. FMXIN002 was well tolerated with no significant adverse effects.
Nasus Pharma CEO Dalia Megiddo commented, “The results of the study with FMXIN002 powder intranasal epinephrine show that it can provide a safer and more effective rescue for the emergency treatment of life-threatening allergic reactions by providing an easy-to-use device and quicker absorption of epinephrine.”
Megiddo 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 for this immediate period. Failure to administer epinephrine promptly has been identified as the most important factor contributing to death in patients with allergies. Parents and care givers are often reluctant to give injections. A user-friendly simple nasal inhaler could make the much- needed rescue therapy be given in time. This, in addition to the significantly shorter time to therapeutic blood levels and higher dose in the relevant first half an hour FMXIN002 could change dramatically the risks associated with severe allergy and anaphylaxis.”
Chairman of the Board Udi Gilboa said, “It is well established that powder nasal drugs enjoy better bioavailability, quicker absorption and better stability compared to fluid nasal formulations. Nasus Pharma’s robust intranasal powder technology is proven again to deliver significantly quicker higher doses of rescue therapy in cases of medical emergencies where immediate therapy is needed. As with our naloxone program now heading towards NDA, Nasus Pharm will continue to move forward with its development programs in collaboration with the regulatory authorities and with its pre-commercialization efforts with all stake-holders.”
Read the Nasus Pharma press release.
