Investigational Cystic Fibrosis Therapy Designated Orphan Drug

Advanced Inhalation Therapies announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to AIT-CF, a high dose formulation of nitric oxide for adjunctive treatment of cystic fibrosis (CF).

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AIT-CF is a proprietary nitric oxide formulation and delivery system designed to deliver a high dose formulation to the lungs using positive air pressure and integrated monitoring parameters. The company’s investigational system has the potential to eliminate microbial infections including bacteria, fungi, and viruses. Nitric oxide is produced naturally by the body as a highly effective antimicrobial defense mechanism, but to date no delivery system has been able to deliver an effective and non-toxic antimicrobial dosage to the lungs.

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