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Amikacin Inhale Shows Promising Results in Phase II Study
Date:5/19/2008

4) or every 12 hours (n=21) for 7-14 days.

Serial serum, tracheal aspirate and urine samples were collected on Day 3. Clinical parameters, such as Clinical Pulmonary Infection Score (CPIS), days on ventilator and intravenous antibiotic use were monitored. In another study healthy volunteers (n=14) inhaled a single dose of 400 mg of amikacin via the proprietary delivery system using the hand held adaptor. This was done to compare the lung doses between on-vent and hand-held adaptors using the same proprietary nebulizer.

Mean peak tracheal aspirate of amikacin after Amikacin Inhale use every 12 hours was 16,212 +/- 3,675 mcg/mL as compared to 14 +/- 4.2 mcg/mL after intravenous administration (15mg/kg per day)(3). After Amikacin Inhale use, peak serum levels of amikacin were 3.2 +/- 0.5 mcg/mL versus 47 +/- 4.2 mcg/mL after intravenous administration. On average, 43 percent of the dose was delivered to the lungs using the hand-held system with a comparable low systemic exposure. The dose delivered to the lungs with the proprietary nebulizer is comparable between the on-vent and hand-held adaptors.

Penetration of Amikacin Inhale in Lower Respiratory Tract(4)

This study evaluated Amikacin Inhale penetration into the fluid lining of the epithelial surface (ELF) of the lower respiratory tract of the pneumonia-infected lung. Treatment was adjunctive to IV treatment. Mechanically ventilated patients (n=28) with Gram-negative pneumonia received 400 mg doses of aerosolized amikacin every 12 hours for 7-14 days. The delivery of aerosolized Amikacin Inhale achieved high aminoglycoside amikacin concentrations in the ELF of the lower respiratory tract, including in the pneumonic area of the lung while maintaining safe serum concentrations. Median ELF levels were 976.1 mcg/mL [135.7-16,127.6], always exceeding the amikacin MIC (minimum inhibitory concentration) for microorganisms usually responsible for Gram-negative pneumonia.

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SOURCE Nektar Therapeutics
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