Phase III MPEX-209 trial data shows efficacy of Quinsair (levofloxacin inhaled solution) in cystic fibrosis- Raptor Pharmaceutical

Raptor Pharmaceutical announced new data analyses of its Phase III clinical study (MPEX-209) comparing Quinsair (levofloxacin inhaled solution) to inhaled tobramycin solution in patients with cystic fibrosis and chronic Pseudomonas aeruginosa infections. The analyses showed that subjects with three or more prior-year pulmonary exacerbations (PEx) who were randomized to receive Quinsair had a significantly lower incidence of PEx when compared with their peers who were randomized to receive the active comparator, tobramycin inhalation solution. The most frequently reported adverse reactions were cough/productive cough, dysgeusia and fatigue/asthenia.

In MPEX-209, over the course of the three on/off cycle 168-day study of inhaled tobramycin or levofloxacin, no significant changes within treatment groups or differences between treatment groups were observed by selective culture with respect to: the proportion of P. aeruginosa (Pa) isolates susceptible to levofloxacin, tobramycin, aztreonam, or meropenem using EUCAST breakpoints and the proportion of Pa isolates not susceptible to at least 3 of these 4 classes. The prevalence of CF bacterial opportunists cultured from study patients did not change significantly within treatment groups or between treatment groups over the course of the study. The most frequently reported adverse reactions were cough/productive cough, dysgeusia and fatigue/asthenia. Data were presented at the 39th European Cystic Fibrosis Conference.