Raptor Pharmaceutical Corp. announced that the first commercial sales of Quinsair (levofloxacin inhalation solution), a treatment for adults with cystic fibrosis, have been made in Denmark and Germany.
Quinsair is an antibiotic for the twice-daily treatment of long-term lung infection caused by the bacteria Pseudomonas aeruginosa in adults with cystic fibrosis (CF). P. aeruginosa is a prototypical “multidrug resistant (MDR) pathogen” recognized for its ubiquity, and its intrinsic and advanced resistance to antibiotic treatment. P. aeruginosa is a frequent cause of infections in CF, an inherited disease marked by an accumulation of thick mucus in the lungs promoting bacterial growth.
The active substance in Quinsair, levofloxacin, belongs to the group of antibiotics known as fluoroquinolones. It works by blocking enzymes that P. aeruginosa bacteria use to make copies of its DNA during cell multiplication. Through this mechanism of action, Quinsair can stop bacterial growth and multiplication.
Quinsair is approved in Canada and the European Union for adult CF patients who are chronically infected with P. aeruginosa. The company is working toward approval from the U.S. Food and Drug Administration.
The medication’s safety was evaluated in two double-blind, placebo-controlled studies, and in an active comparator study. The most frequently reported adverse reactions were cough/productive cough, dysgeusia, and fatigue/asthenia.
Quinsair is the first fluoroquinolone to be approved as an inhaled therapy for a pulmonary disease. Raptor anticipates other launches of the product in Canada and elsewhere in the European Union this year.
“Raptor is excited to offer a new, first-in-class inhaled antibiotic treatment option for the many patients and families living with cystic fibrosis and battling chronic bacterial lung infections. We are beginning the European launch of QUINSAIR in Germany and Denmark, and continue to pursue approval of QUINSAIR for CF patients in the United States,” Dave Happel, Raptor’s chief commercial officer, said in a press release.
“We are confident that QUINSAIR will be an important growth driver for Raptor. We expect QUINSAIR to increase our revenue base and enhance our long-term growth profile while leveraging our commercial and development expertise and our existing global infrastructure,” Happel concluded.