Transave reported positive results from its Phase 2 trial in non-cystic fibrosis (CF) bronchiectasis patients for its lead investigational drug, Arikace (liposomal amikacin for inhalation). This double-blind, placebo-controlled study was designed to evaluate Arikace in non-CF patients who have bronchiectasis with Pseudomonas lung infections. Sixty-four adult patients were randomized to receive Arikace – either 280 mg or 560 mg daily dosages – or placebo. Patients received 28 days of therapy followed by a 28-day off-treatment observation period. Arikace and placebo were administered once daily using an eFlow Nebulizer System (PARI Pharma GmbH), a portable aerosol delivery system. The data indicated that Arikace, delivered once daily for 28 consecutive days, demonstrated superior clinical benefit compared to placebo as measured by patient and physician reported outcomes and reduction in Pseudomonas aeruginosa density. In addition, ARIKACE was well-tolerated with overall adverse events comparable to placebo.
Arikace is a formulation of the antibiotic amikacin, enclosed in nanocapsules of lipid called liposomes and delivered by the eFlow Nebulizer System. This formulation is designed to prolong the release of amikacin in the lungs while minimizing systemic exposure.
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