Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has granted Orphan Drug Designation for Advanced Inhalation Therapies' (AIT's) high dose formulation of nitric oxide (NO) and delivery system, AIT-CF, as adjunctive treatment of cystic fibrosis (CF).
Subscribe to our email newsletter
AIT-CF is designed to deliver a high dose formulation (160 ppm) to the lungs using positive air pressure and integrated monitoring parameters.
The new delivery system has the potential to reduce microbial infections including bacteria, fungi and viruses.
Advanced Inhalation Therapies chief executive officer Amir Avniel said: "Airway phlegm that contains bacterial colonizations and infections is the primary complication of CF.
"Inhalation of NO has demonstrated anti-infective, anti-inflammatory and vasodilating properties in CF patients.
"The results from our completed Phase II open label, multi-center study of CF patients over ten years of age demonstrated the safety and efficacy of our product candidate."
The company’s proprietary system continuously monitors safety and efficacy parameters in the patient and is adaptable to treat a wide range of lung infections.
Nitric oxide is produced naturally by the body as a highly effective antimicrobial defense mechanism, but to date no system has been able to deliver an effective and non-toxic antimicrobial dosage to the lungs.