Pharmacokinetic Profile of Liposomal Amikacin for Inhalation in Patients With Cystic Fibrosis and Chronic Pseudomonas aeruginosa Infection

• A phase 3 trial, the Clinical Evaluation of ARIKAYCE™ (CLEAR)-108 study, compared the efficacy, safety, and tolerability of LAI vs tobramycin inhalation solution (TIS), USP, over 3 treatment cycles for the management of P. aeruginosa infection in patients with CF. – LAI administered once daily was found to be comparable to TIS administered twice daily in improving lung function by the third on-treatment period. – Patients treated with LAI reported significantly greater improvement in respiratory symptoms at the end of the third on-treatment period compared with those treated with TIS. – The majority of adverse events (AEs) associated with LAI were respiratory in nature and decreased from treatment Cycle 1 to treatment Cycle 3, suggesting decreasing frequency of treatment-associated AEs with continued use of LAI.