Inhaled Antifungal Granted Orphan Drug Status for Cystic Fibrosis

The Food & Drug Administration has granted Orphan Drug designation to PUR1900 (Pulmatrix) for the treatment of pulmonary fungal infections in patients with cystic fibrosis (CF).

Recent studies have shown that oral itraconazole is effective in treating fungal lung infections in patients with CF. However, due to the high oral doses needed to reach the lungs, severe adverse events such as liver toxicity are concerning, requiring appropriate monitoring and management. 

PUR1900 is an inhaled antifungal which combines itraconazole and Pulmatrix’s iSPERSE technology, the company’s proprietary dry powder delivery platform to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects.

For more information visit Pulmatrix.com.