From Earlier: Forest Laboratories Receives European Marketing Approval for Colobreathe Dry Powder Inhaler

Forest Laboratories, Inc. FRX today announced that it has been granted European Medicines Agency approval to market Colobreathe dry powder colistimethate sodium for inhalation for treating cystic fibrosis patients aged 6 years and older with chronic lung infection caused by P. aeruginosa. The pivotal clinical study of Colobreathe demonstrated the benefits and its ability to prevent deterioration of respiratory function in Cystic Fibrosis patients. The pivotal study which was submitted to EMA for authorization was an open-label active comparator study comparing the efficacy of Colobreathe to TOBI (tobramycin nebuliser solution for inhalation). This study also demonstrated better patient acceptability of Colobreathe. Importantly, data from the study of Colobreathe showed that overall the product was well tolerated and there was no emergence of antibacterial resistance.