According to PureIMS, both the EMA and FDA have recently granted orphan drug designation to the company’s Colistin Cyclops dry powder inhaler for the treatment of P. aeruginosa infections in cystic fibrosis patients. Colistin Cyclops is currently in Phase 1 development and is available in the Netherlands for the treatment of pulmonary P. aeruginosa infections as a compounded product through a named patient program. In September 2024, PureIMS announced that Fagron had acquired exclusive rights to distribute PureIMS’s Cyclops dry powder inhaler with compounded inhalation powders in the Netherlands.
PureIMS said that Colistin Cyclops has shown significant benefits compared to nebulized medications and other dry powder therapies that are currently available to CF patients, with patients reporting that the Cyclops product was more convenient than nebulized treatments and early clinical data showing a significant reduction in cough compared to other powders.
PureIMS CEO Jaap Wieling commented, “This orphan drug designation by both regulatory agencies is an important recognition of an unmet need for inhaled antibiotic treatments that are less burdensome to cystic fibrosis patients. It allows PureIMS to intensify discussions with EMA and FDA on the best development approach for Colistin Cyclops, potentially leading to accelerated regulatory pathways, such as conditional marketing authorization (EMA) or expedited review (FDA).”
Read the PureIMS press release.
