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Press Release

TOBI® Podhaler® (tobramycin inhalation powder), the first antibiotic inhaler, for the suppression of chronic Pseudomonas aeruginosa in cystic fibrosis, launches in the UK

Novartis
Posted on: 20 Sep 11

TOBI® Podhaler® (tobramycin inhalation powder), the first antibiotic inhaler, for the suppression of chronic Pseudomonas aeruginosa in cystic fibrosis, launches in the UK

  • A new dry powder form of the established antibiotic tobramycin is now available in a hand-held inhaler (Podhaler) for the suppression of chronic Pseudomonas aeruginosa (Pa) lung infection in adults, adolescents and children aged 6 years and older with cystic fibrosis1
  • Data show that therapy with tobramycin inhalation powder significantly decreases treatment time; providing a 72% reduction in overall treatment time compared with nebulised TOBI® (tobramycin nebuliser solution)2
  • Cystic fibrosis is a life-threatening genetic disease, which usually requires numerous and complex daily treatment regimens, creating a high treatment burden for people living with this condition3

Frimley, UK, 20 September 2011 – TOBI® Podhaler® (tobramycin inhalation powder) is now licensed and available for the suppressive treatment of chronic pulmonary infection due to Pseudomonas aeruginosa (Pa) in adults and children aged 6 years and older with cystic fibrosis (CF).1 This innovative drug-device delivers a dry powder formulation of the antibiotic tobramycin via a hand-held inhaler that is quick and convenient to use.1,2

There are just over 9,000 people living with CF in the UK today,4 most of whom develop a chronic pulmonary infection. Infection of the respiratory tract continues to be the leading cause of morbidity and mortality in people with CF,5 with approximately 60% of CF patients developing a Pa infection by the age of 23.6

To manage all aspects of their condition, cystic fibrosis treatments can take up to 2 hours a day to complete.7 This routine is constant and unchanging, even at weekends, as explained by Professor Stuart Elborn, Professor of Respiratory Medicine at Queen’s University, Belfast, “People with CF have to endure a lengthy regimen of treatments and physiotherapy every day, so the time saved using tobramycin inhalation powder compared to nebulised tobramycin is significant”.

Tobramycin nebuliser solution is a commonly prescribed antibiotic for chronic Pa infections in people with CF and has a substantial evidence base.8,9,10 The new formulation, tobramycin inhalation powder is a novel dry powder, which has been produced using patented PulmoSphere® technology to deliver light, porous tobramycin particles that require low inspiratory effort to be inhaled deep into the lungs.7

Clinical trial data show that tobramycin inhalation powder provides comparable efficacy to tobramycin nebuliser solution.2 The new dry powder formulation offers the clinical benefits of improved lung function and reduced hospitalisations, compared to placebo,11 with the advantage of significantly greater convenience and patient satisfaction compared to nebulised tobramycin.2 Importantly, those using the new tobramycin inhalation powder completed their treatment in just 5 to 6 minutes; significantly faster than tobramycin nebuliser solution, which takes approximately 20 minutes to administer.2 For a twice-daily regimen, this equates to a significant time-saving of approximately 28 minutes per day.2

In addition to the time savings, the dry powder formulation means the likelihood of bacterial growth in the device is low, as the new hand-held, plastic inhaler requires minimal setup and can be wiped clean with a dry cloth.7 This is an advance in CF medication as research shows that over 60% of people with CF fail to clean their nebulisers as directed, and 65% of nebulisers are contaminated with bacteria.12 The new plastic inhaler is light-weight, portable and, unlike a nebuliser, has no need for an external power source or batteries, and the tobramycin dry powder capsules do not require refrigeration.1,7,8

Dr Tim Cave, Medical Director from Novartis Pharmaceuticals UK commented, “We are proud to be launching TOBI Podhaler; a product that clearly demonstrates how we are applying innovative technology to better meet the needs of people with CF, helping them to lead independent and active lives”.

The majority of adverse reactions reported with tobramycin inhalation powder were mild to moderate,2 and the incidence of serious adverse events was shown to be similar between tobramycin inhalation powder and tobramycin nebuliser solution. The safety of tobramycin inhalation powder has been studied in two separate clinical trials.2,11 The most commonly reported adverse events in the main safety study, where tobramycin inhalation powder was compared to tobramycin nebuliser solution, were cough, lung disorder, productive cough, pyrexia, dyspnoea, oropharyngeal pain and dysphonia.1,2

CF is a life-threatening genetic disease that clogs internal organs with thick sticky mucus notably within the lungs and digestive system; making it hard to breathe and digest food.4 As a result, symptoms of CF include malnutrition and cough, and these usually develop within the first year of life. At present the average lifespan for people with CF is 38 years.4

Ends -

Notes to editors

About TOBI® Podhaler® (tobramycin inhalation powder)

Tobramycin inhalation powder is the first dry powder formulation of tobramycin.1 The new dry powder formulation is contained in a capsule, which is inserted into the Podhaler for actuation and inhalation. Inhaling through the Podhaler makes the capsule spin rapidly as it empties.7

Tobramycin inhalation powder is the first licensed treatment to be formulated using PulmoSphere® technology.1,7 This is an emulsion-based spray-drying process that enables the production of light-porous-particle dry powder formulations. The result is greater control of particle size and distribution, porosity, density and surface energy compared to traditional micronized powders, aiding deposition in the lung.7

Tobramycin inhalation powder has a recommended dosage of four capsules (4 x 28 mg = 112 mg tobramycin), administered twice daily for 28 days (alternating cycles of 28 days on treatment followed by 28 days off treatment).1 The two doses (of 4 capsules each) should be inhaled as close as possible to 12 hours apart and not less than 6 hours apart.1

Patient-reported satisfaction was rated using a TSQM (Treatment Satisfaction Questionnaire for Medication). Convenience and satisfaction were rated higher with tobramycin inhalation powder compared with tobramycin nebuliser solution (a higher score indicated higher satisfaction).2 Patient reported side effects ratings on the TSQM questionnaire showed no difference between treatment groups.2

About Pseudomonas aeruginosa and nebulised treatments

Pseudomonas aeruginosa (Pa) is the most common respiratory pathogen found in adults,6 with CF and has a particularly profound effect on the lungs. The prevalence of Pa increases with age.6 CF patients may not notice any signs of infection, but as the infection becomes more severe, they may notice symptoms, including: coughing, difficulty in breathing, wheezing, lack of appetite, fatigue and weight loss.

Existing nebulised Pa treatments may be time consuming and complex as administration alone can take up to 40 minutes a day, and on top of that there are additional requirements for cleaning and frequently the need for the nebuliser to be connected to an external power supply.2,7 These treatments are often taken last in the treatment schedule, and as patients run out of time in the rush to get to school or work, they may be missed or forgotten. The degree of effort and time needed for adherence with nebulised antibiotics can account for up to 60% of missed doses.14

# # #

References


1.TOBI Podhaler Summary of Product Characteristics
2.Konstan MW, et al. J Cyst Fib 2011; 10: 54-61
3.Sawicki GS, et al. J Cyst Fib 2009; 8: 91-96
4.Cystic Fibrosis Trust, 2011. http://www.cftrust.org.uk/. Accessed July 2011
5.LiPuma JJ, et al. Clin Microbiol Rev 2010; 23 (2): 299-323
6.UK CF Registry Annual Data Report 2009. http://www.cftrust.org.uk/aboutcf/publications/cfregistryreports/Final_UK_Cystic_Fibrosis_Registry_Report_2009.pdf Accessed July 2011
7.Geller DE, et al. J Aer Med and Pulm Drug Deliv 2011; 24: 1-8 http://www.liebertonline.com/doi/pdf/10.1089/jamp.2010.0855. Accessed July 2011
8.TOBI Summary of Product Characteristics http://www.medicines.org.uk/emc/medicine/19020/spc/ Accessed July 2011
9.Ramsey BW, et al. N Engl J Med 1999; 340: 23-30
10.Moss RB, et al. Chest 2001; 120: 107S-113S
11.Konstan MW, et al. Ped Pulm 2011; 46: 230-238
12.Blau H, et al. Child Care, Health Dev. 2007; 33 (4): 491-495
13.VanDevanter DR, et al. Respiratory Research 2010; 11: 137-144
14.Conway SP, et al. Thorax 1996; 51: 29-33
Novartis Media Relations

Novartis UK Press Office

T : 01276 69861

Pressoffice-uk.phgbfr@novartis.com


Gemma Rickwood, Packer Forbes

T: 0207 036 8550

gemma@packerforbes.com


 

Editor's Details

Lydia Meakin
Packer Forbes
020 7036 8550
lydia@packerforbes.com

Last updated on: 20/09/2011

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