- Significantly higher rapid absorption of Naloxone – may be critical to rescue of over-dose victims.
- Excellent safety profile.
- NDA submission planned for later this year.
TEL AVIV, Israel, April 13, 2021 /PRNewswire/ -- 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.
Because Naloxone is a competitive opiate receptor antagonist, its efficacy in reversing overdose depends on both the quantity of opioids used and their relative affinities for opiate receptors. This information is rarely available to first responders (or bystanders) attempting to resuscitate a suspected overdose, therefore immediate and effective treatment is critical.
Over 81,000 drug overdose deaths occurred in the United States in the 12 months ending in May 2020, the highest number of overdose deaths ever recorded in a 12-month period, according to recent provisional data from the Centers for Disease Control and Prevention (CDC)[i]. This is especially relevant because of the dramatic rise in the abuse of high-potency opioids such as fentanyl that requires higher concentrations of Naloxone to treat overdose. Indeed, field studies show that about a third of opioid overdose victims will need a second dose within the first few minutes and about 16% will need a third dose.
"The results announced today demonstrate the impressive advantages of Nasus Pharma powder-based intranasal technology combined with the tested reliability of Aptar Pharma's Unidose Powder device," said Dr. Dalia Megiddo, Nasus Pharma co-founder and CEO. "The advantages of intranasal administration of Naloxone in the treatment of opioid overdose are well established, and absorption of our powder-based Naloxone to the blood in the first few minutes could signify higher lifesaving effect especially in patients with serious respiratory depression. We are focused on our NDA submission later this year with an objective to commercialized FMXIN001 in 2022."
Udi Gilboa, Nasus Executive Chairman and Nasus Pharma co-founder added: "The current COVID pandemic masked the ongoing pandemic of opioid overdose in the public eye, despite the fact that it contributed to the alarmingly increased use of high potency opioids and the rising mortality from overdose. We believe FMXIN001, with its very well differentiated IP protection, can be a more effective way to deal with this critical public-health threat, and to better treat victims of opioids overdose non-invasively and safely. We are working toward commercial readiness during 2022."
Nasus Pharma IP protected powder-based composition for intranasal delivery is comprised of uniform spherical API's and a carrier approved for inhalations. The active compound's shape, size, and morphology in combination with a device provides rapid and precise delivery of the drug to the blood stream. FMXIN001 is a combination drug device using Aptar Pharma's Unidose Powder device. Each single use device contains 4 mg of Naloxone powder. More details can be found on the Nasus Pharma website.
About Nasus Pharma
Based on its unique microsphere technology, Nasus Pharma is developing a number of intranasal powder products aimed at assisting patients in several acute emergency situations such as opioid overdose and anaphylactic shock.
Intranasal administration is most suitable for those situations in which rapid drug delivery is required and offers multiple advantages such as rapid drug delivery, ease of use, non-invasiveness, and safety. Nasus's portfolio comprises a number of programs: Intranasal Naloxone completed pivotal study and Intranasal Epinephrine (phase 2) as well as a number of preclinical POC programs.