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Amikacin (Arikace) Meets Primary Endpoint in Phase III Cystic Fibrosis Trial
Drug is non-inferior to tobramycin in treating P. aeruginosa infection (July 1)
Positive results have been reported from the clinical development program for Arikace (liposomal amikacin for inhalation [LAI], Insmed Incorporated).
In a phase III study, once-daily Arikace to treat Pseudomonas aeruginosa infection in cystic fibrosis (CF) patients met its primary endpoint of non-inferiority compared with twice-daily TOBI (tobramycin inhalation solution, Novartis) for the relative change in forced expiratory volume in 1 second (FEV1), measured at the end of the third treatment cycle (24 weeks), compared with baseline.
The FDA has granted “fast track” designation to Arikace for the treatment of non-tuberculous mycobacteria (NTM) lung infections.
The phase III trial was an open-label, randomized study designed to assess the comparative safety and efficacy of Arikace and TOBI in CF patients with P. aeruginosa infection. A total of 302 adult and pediatric CF patients with chronic infection were randomly assigned to receive 28 days of Arikace treatment delivered once-daily via an investigational nebulizer system (eFlow), or TOBI delivered twice-daily via the Pari LC Plus nebulizer for 24 weeks.
Arikace is a form of the antibiotic amikacin, which is enclosed in nanocapsules of lipid called liposomes. This technology prolongs the release of amikacin in the lungs while minimizing systemic exposure. The treatment uses biocompatible lipids endogenous to the lung that are formulated into small (0.3-micron), charge-neutral liposomes.
Source: Insmed Incorporated; July 1, 2013.