Novartis Ireland launches TOBI® Podhaler® for cystic fibrosis patients
TOBI Podhaler is a new dry powder form of tobramycin for treating chronic Pseudomonas aeruginosa lung infection in cystic fibrosis (CF) patients over six. Data show new formulation reduces administration time by 72% compared to TOBI, with same efficacy1 and using more convenient, patient-friendly device. CF is a life-threatening genetic disease primarily affecting children and young adults – complex daily treatment reduces their ability to lead normal lives.
TOBI® Podhaler® (tobramycin inhalation powder), a fast and convenient inhaled therapy1 for patients with cystic fibrosis (CF), has been approved in the European Union since 22nd July 2011 as a suppressive therapy for chronic Pseudomonas aeruginosa (Pa) lung infections in CF patients aged six years and older.
EU approval was based on data showing that TOBI Podhaler provides the same efficacy2 as TOBI® (tobramycin solution) with a comparable safety profile2. TOBI is the most widely used inhaled antibiotic for chronic Pa infections in CF3. TOBI Podhaler has a unique dry powder formulation, developed using novel PulmoSphere® technology to produce particles that are light and porous for deep delivery into the lung. This means treatment can be given with a portable, patient-friendly device, in contrast to TOBI which is administered with a nebulizer.
Data show that patients using TOBI Podhaler completed their tobramycin treatment in five to six minutes instead of 20 minutes with TOBI, a reduction of 72%1. Nebulized treatments require additional time for assembly and disinfection, unlike TOBI Podhaler, which also does away with the need for refrigeration of the active compound and a power source for the delivery device. A study found that patients treated with TOBI Podhaler had significantly higher treatment satisfaction than those treated with TOBI1.
Due to the complexity of existing anti-Pa treatment, most patients do not fully adhere to their therapy3,4,5. In addition, many patients do not clean their nebulizers properly and these are often contaminated6,7,8,9,. With TOBI Podhaler, the inhaler device is disposable and the dry formulation potentially reduces the risk of bacterial contamination.
http://www.novartis.com
References:
1. Konstan MW, Flume PA, Brockhaus F. Safety and efficacy of tobramycin inhalation powder (TIP™) in treating cystic fibrosis patients infected with Pseudomonas aeruginosa (Pa). Poster and abstract presented at 33rd European Cystic Fibrosis Congress, 17 June 2010.
2. Flume PA, O'Sullivan BP, et al. Cystic fibrosis pulmonary guidelines: chronic medications for maintenance of lung health. Am J Resp Crit Care Med 2007; 176:957-69.
3. Modi A, Lim CS, et al. A multi-method assessment of treatment adherence for children with cystic fibrosis. J Cyst Fibros 2006; 5:177-85.
4. Latchford G, Duff A, et al. Adherence to nebulised antibiotics in cystic fibrosis. Patient Educ Couns 2009; 75:141-44.
5. Briesacher BA, Quittner AL, et al. Adherence to tobramycin inhaled solution and health care utilization. Am J Resp Crit Care Med 2009; 179:A1183.
6. Saiman L, Siegel J. Infection control recommendations for patients with cystic fibrosis: microbiology, important pathogens, and infection control practices to prevent patient to patient transmission. Infection Control and Hospital Epidemiology 2003; 24:S6-S52
7. Lester MK, et al. 2004. Nebulizer use and maintenance by cystic fibrosis patients: a survey study. Respir Care. 2004 Dec;49(12):1504-8.
8. Blau H, Mussaffi H, Mei Zahav M, et al. Microbial contamination of nebulizers in the home treatment of cystic fibrosis. Child Care Health Dev 2007; 33:491-95.
9. Rosenfeld M, Emerson J, Astley S, et al. Home nebulizer use among patients with cystic fibrosis. J Pediatr 1998; 132:125-31.
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