EMA approves Colobreathe (Forest Labs) for Cystic Fibrosis

European Medicines Agency (EMA)has given approval to market Colobreathe dry powder colistimethate sodium for inhalation, from Forest Laboratories Europe, for the treatment of Cystic Fibrosis in patients aged 6 years and older with chronic lung infection caused by P.aeruginosa. 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. Forest Laboratories Europe has marketed a nebulised form of colistimethate sodium, an antibiotic used to treat the principal bacterial infections in cystic fibrosis patients, under the brand name Colomycin, in the UK and Ireland for many years. In 2011 Forest Laboratories acquired all rights held by Gruenenthal to colistimethate sodium in several European countries and also reacquired rights to Colobreathe previously licensed from Forest.Instead of requiring up to thirty minutes of inhalation from a nebuliser Colobreathe is an advance to aid patient compliance and convenience utilizing the Turbospin inhaler which is small enough to be easily carried and is easy to administer the necessary dose in less than a minute.