TOBI Podhaler Approved to Manage Cystic Fibrosis
Novartis announced that the FDA has approved TOBI Podhaler (tobramycin inhalation powder) for the management of cystic fibrosis in patients with Pseudomonas aeruginosa (Pa) bacteria in the lungs. TOBI Podhaler is a novel, non-nebulized formulation and delivery system of tobramycin, an aminoglycoside antibiotic.
TOBI Podhaler delivers tobramycin into the patient's lungs via a pocket-sized dry powder inhaler using the company's proprietary PulmoSphere technology. When the capsule is placed into the Podhaler device, the porous particles of tobramycin are then delivered as a dry powder. It contains the same active ingredient as TOBI (tobramycin inhalation solution) 300mg/5mL, which is administered using a nebulizer. The TOBI Podhaler does not need to be refrigerated and does not require a power source to operate the device.
In a Phase 3 clinical program (n=674), TOBI Podhaler shortened administration time for patients by approximately 70% vs. TOBI, saving about 13 hours per treatment cycle in patients >6 years.
TOBI Podhaler will be available in 28mg capsules in 224-count boxes (4 weekly packs). TOBI Podhaler is expected to be available in the second quarter of 2013.
For more information call (877) 999-8624 or visit www.tobipodhaler.com.