Pharmaceutical Business review

FDA grants orphan drug status for AIT’s high dose nitric oxide formulation to treat CF

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.