Nasus Pharma said that a bioequivalence study of its FMXIN001 dry powder intranasal naloxone demonstrated that FMXIN001 was absorbed significantly faster than Emergent BioSolutions’ Narcan naloxone nasal spray, with an AUC 163% of the Narcan AUC after 4 minutes, and continued to demonstrate higher levels of naloxone in the blood through the first hour post dosing. The study, which enrolled 42 healthy volunteers, compared a single dose 4 mg dose of FMXIN001 delivered via the Aptar Pharma Unidose powder device to a single dose of Narcan 4 mg/0.1 ml.
Nasus Pharma co-founder and CEO Dalia Megiddo commented, “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. 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.”
Nasus co-founder and Executive Chairman Udi Gilboa said, “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.”
In addition to FMXIN001, Nasus’s pipeline includes an intranasal epinephrine for the treatment of anaphylactic shock. The company also makes Taffix intranasal hydroxypropyl methylcellulose (HPMC) powder for protection against respiratory viruses. In October 2020, Nasus presented real-world data that it said demonstrated the effectiveness of Taffix in protecting against SARS-CoV-2 infection.
Read the Nasus Pharma press release.
