Raptor Pharmaceutical recently announced new clinical data from a Phase 3 trial evaluating the efficacy of Quinsair (levofloxacin) versus tobramycin in cystic fibrosis (CF) patients with chronic pulmonary infections caused by Pseudomonas aeruginosa.
Study results were presented at the 39th European Cystic Fibrosis Conference in Basel, Switzerland.
“Patients with cystic fibrosis have few approved inhaled antimicrobial options for the treatment of chronic Pseudomonas infection and in many cases, continue to have pulmonary exacerbations despite available therapies,” said Dr. Krishna R. Polu, Raptor’s chief medical officer in a press release. “We believe it is critically important to provide physicians with additional data that suggest that Quinsair may reduce the number of pulmonary exacerbations in patients with a history of frequent pulmonary exacerbations.”
In the poster presentation “History of Pulmonary Exacerbations (PEx) as a Predictor of Response to Nebulized Levofloxacin Compared with Nebulized Tobramycin,” the company revealed data from its MPEX-209 Phase 3, randomized, controlled study.
The study compared the inhaled solutions of levoflaxacin versus tobramycin. Patients received treatment during three 28-day cycles separated by 28 days without treatment.
Results showed that patients who had three or more pulmonary exacerbations during the year before treatment had significantly less incidence of exacerbations when treated with levoflaxacin, compared to those taking tobramycin.
“Further analyses suggest that Quinsair administration did not increase the risk for colonization with new pathogens or lead to increased antimicrobial susceptibilities,” Polu said.
Further support was provided via another poster, “Microbiologic Changes Observed over 6 months in a Randomized, Open-Label Comparison of Inhaled Levofloxacin and Inhaled Tobramycin in Persons with CF and Chronic P. aeruginosa (Pa) Airway Infection.“
Through the poster, researchers demonstrated whether the patients enrolled in the MPEX-209 study had differences in the proportion of P. aeruginosa isolates that were susceptible to levofloxacin, tobramycin, meropenem, or aztreonam, or not susceptible to at least three of the four classes of drugs. The team found that there were no significant differences over the course of the study across treatment groups.
Also noted were no changes in the prevalence of CF bacterial opportunists cultured from the patients of the MPEX-209 study – within or between treatment groups.
Adverse reactions to levofloxacin included cough, alteration in taste, and fatigue.
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