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Pulmatrix Receives Orphan Drug Designation from the FDA for Inhaled Drug to Treat Pulmonary Fungal Infections in Cystic Fibrosis Patients

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Additional Relevant Details "This designation is a major boost to our efforts to make this drug available as quickly as possible to cystic fibrosis patients who currently suffer from fungal infections in their lungs, and from the allergic reactions they experience because of the fungal infections," says Pulmatrix CEORobert Clarke, PhD.Pulmatrix's PUR1900 combines an existing antifungal drug, itraconazole, with the company's innovative dry powder iSPERSE technology, enabling patients to easily inhale the drug deep into their lungs where it's needed. Recent studies have shown that, taken orally, itraconazole is effective in treating allergic reactions in CF patients who have fungal lung infections. However, high oral doses are needed to get enough of the antifungal drug to the lungs through the bloodstream. That causes severe side effects that must be managed and monitored—including liver toxicity.
http://ir.pulmatrix....
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Occurred on:
Aug 17, 2016
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Related Keywords Orphan Drug, Pulmonary Fungal Infections, Cystic Fibrosis, Pur1900