Raptor Pharmaceutical Corp. announced its first commercial sale of Quinsair, a levofloxacin inhalation solution, in Germany and Denmark. The European Union (EU) and Canada have already approved Quinsair for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adults with cystic fibrosis (CF).
Quinsair is the first fluoroquinolone to be approved as an inhaled therapy for a pulmonary disease. It is administered through the efficient Zirela nebulizer system (PARI Pharma GmbH) that allows delivery of high concentrations of the active drug directly to the infection site in about five minutes.
Cystic fibrosis is a rare, life-threatening inherited disease that affects nearly 75,000 people around the world, and is caused by mutations in the CF transmembrane conductance regulator (CFTR) gene. A defective or missing CFTR protein leads to poor salt and water flow into and out of cells in a series of internal organs, including the lungs. This can lead to the build-up of unusually thick secretions that might cause chronic lung infections and progressive lung damage, eventually putting the patient’s life in danger.
Patients with hypersensitivity to levofloxacin, a history of tendon disorders related to fluoroquinolones, diagnosed epilepsy, or patients who are or might be pregnant, or who are breastfeeding, should not take Quinsair. The treatment is indicated for administration twice a day with a short administration time.
“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 said.
Quinsair drug’s safety was assessed in two double-blind, placebo-controlled clinical trials: NCT00503490 and NCT01180634. Launches of Quinsair in additional EU countries and Canada are expected this year.