Nasus Pharma Ltd, a clinical-stage biopharmaceutical company focused on developing needle-free, powder-based Intranasal (PBI) specialized product portfolio to address acute medical conditions & public health threats, announced positive results from a pivotal trial of intranasal powder-based Naloxone.
The results of this single-dose, bioequivalence study of FMXIN001 4 mg microspheres powder and Narcan® 4 mg/0.1 ml nasal spray showed that FMXIN001- Nasus Pharma powder-based Naloxone was absorbed significantly faster into the blood. Most notably in the first minutes and up to one hour, FMXIN001 created significantly higher blood levels of Naloxone during the critical time frame for life-saving treatment of opioid overdose.
Area Under Curve (AUC) measured after nasal inhalation of FMXIN001 in the first 4 minutes was 163% compared to solution-based Narcan® ( p=0.005), 125% after 10 minutes ( p=0.047), and AUC between 10-30 minutes was 113% compared to Narcan® ( p=0.01) whereas Cmax was 113% ( p=0.003). 42 health volunteers participated in the study. All side effects were minor and self-resolving, representing an excellent safety profile.
The immediate timeframe for treating victims of the opioid overdose by public health emergency is extremely short and getting Naloxone quickly into the blood stream could have a critical influence on patient’s condition and mortality risk. The rapid rise in Naloxone levels in the blood may be advantageous for reversing respiratory depression in opioid overdose. The superior absorption profile and the superb safety can position FMXIN001 as the leading overdose reversing drug.
