2024 Volume 77 Issue 2 Pages 121-133
Introduction: A formulation of laninamivir octanoate that is administered using a nebulizer was developed to facilitate drug delivery in patients who have difficulty using powder inhalers, including young children. This study evaluated the efficacy and safety of this new formulation of laninamivir octanoate in pediatric patients with influenza infection.
Methods: This multicenter, uncontrolled, open-label phase 3 study enrolled Japanese pediatric patients aged <10 years with influenza virus A or B infection. Patients were treated with a single inhalation dose of laninamivir octanoate administered using a nebulizer. The primary endpoint was duration of influenza; the secondary endpoint was time to recovery of a normal body temperature (≤37.4°C). Adverse events (AEs) were assessed for safety.
Results: In total, 173 patients were enrolled and treated with laninamivir octanoate. The median (95% confidence interval [CI]) influenza duration (primary endpoint) was 49.0 hr (43.0, 61.0). The median (95% CI) time to recovery of a body temperature ≤37.4°C (secondary endpoint) was 31.1 hr (25.8, 33.7). Thirty-five patients (20.2%) experienced AEs, and one AE of nausea during inhalation resulted in treatment discontinuation. There were no deaths or serious AEs reported.
Conclusions: In this first clinical trial to evaluate a nebulizer formulation in pediatric patients (aged <10 years) with influenza, it was suggested that a single dose of laninamivir octanoate 160 mg administered using a nebulizer was safe and well tolerated in these patients.
