ARTICLE | Clinical News

Arikace: Additional extension study data

November 1, 2010 7:00 AM UTC

Additional data from an ongoing, open-label extension of the double-blind, placebo-controlled Phase II TR02-105 trial in 49 patients showed that once-daily 560 mg Arikace for 28 days followed by 56 days off-treatment for 5 cycles significantly improved forced expiratory volume in 1 second (FEV1) by 8.4% from baseline to the end of treatment during each cycle (p<=0.0001), and by 6.5% to the end of each 56-day off-treatment period during each cycle (p=0.0018). Patients will receive 6 cycles of treatment consisting of once-daily 560 mg Arikace administered with the eFlow Nebulizer system from Pari GmbH (Starnberg, Germany) for 28 days, followed by 56 days off-treatment. Data were presented at the North American Cystic Fibrosis meeting in Baltimore. ...