Lives unaffected by cystic fibrosis

DRUG DEVELOPMENT PIPELINE

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Inhaled Solistin (Colifin®)

Phase Three

Phase Three

Therapeutic Approach

Anti-Infective

Inhaled colistin is an antibiotic being studied to potentially treat chronic Pseudomonas aeruginosa infections in people with cystic fibrosis (CF). Although it is approved in Europe, inhaled colistin is not approved for use in the U.S. Currently, the only approved inhaled antibiotics in the U.S. are tobramycin and aztreonam. However, many people with CF find that over time these therapies become less effective at treating their infections. Additionally, because there are few oral antibiotics that treat Pseudomonas, people with CF often must go on IV antibiotics when they have pulmonary exacerbations, a sudden worsening of respiratory symptoms caused by lung infections. IV antibiotics are problematic because they can cause hearing loss and kidney problems. Inhaled colistin could provide an additional option to help people with CF who are not responding to current treatments.

Status

Inhaled colistin is approved in Europe. In the U.S., toxicity studies are planned to confirm potentially safe dosages of the drug, in addition to a phase 3 study to test the drug’s safety and effectiveness in people with CF.

Sponsor

This program is sponsored by Spexis and partially funded by the Cystic Fibrosis Foundation. Clinical trials will be conducted through the Therapeutics Development Network.



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