- The Mundipharma network of independent associated companies today announces that flutiformk-haler is now available in Europe for adults and adolescents (aged 12 years and older) with asthma where the use of a combination product (inhaled corticosteroid [ICS] and long-acting β2-agonist [LABA]) is appropriate.[1]  NAPP has launched flutiformk-haler in the UK, marking the first country where the product is available, and further launches are anticipated across European countries in the coming months. flutiformk-haler was approved through the European Decentralised Procedure (DCP), with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) acting as the Reference Member State for the DCP, which covers 18 countries across Europe.

     (Logo: https://mma.prnewswire.com/media/685081/Mundipharma_Logo.jpg )

k-haler is an award-winning[3] breath-triggered aerosol device utilising a patented "kinked" valve – the k-valve™ which has been designed with the aim to make it easier for patients to use correctly. flutiform k-haler will be the first breath-triggered ICS/LABA combination aerosol inhaler available in Europe. flutiformk-haler contains fluticasone propionate and formoterol and is available in two strengths (50/5μg and 125/5μg). It is administered as two puffs (actuations) twice daily.[1]

"This launchis great news for patients with asthma in Europe, who will have the potential to benefit from this new inhaler," commented Alberto Martinez, President and CEO, Mundipharma International Limited. "Patients can struggle to use their inhalers correctly and make critical errorswhich is associated with poor asthma control and increased exacerbations. This simple breath-triggered inhaler has been designed with patients in mind, requiring only agentle inhalation to trigger the dose release, with the aim to help patients reduce critical errors andimprove long-term outcomes."

flutiform k-haler is the same combination as Mundipharma's existing maintenance combination treatment, flutiform pMDI (pressurised metered dose inhaler).[1] The efficacy and tolerability of flutiform pMDI is supported by extensive clinical evidence and real-world use for over five years across Europe and Asia-Pacific regions.[4],[5],[6],[7]

Studies have shown effective drug delivery with the k-haler device. In a gamma scintigraphy study, flutiformk-haler delivered a mean total lung deposition of 43% of the metered dose in asthma patients.[8] Another study also highlighted ease of use with flutiform k-haler; almost all patients (93%) performed correct handling of the k-haler device at their first or second attempt after training.[9]

Asthma is a debilitating long-term health condition that remains a major problem for almost 30 million children and adults under the age of 45 in Europe despite a range of available treatments.[10] Sub-optimal asthma control remains a major problem for patients in Europe.[11]  Poor asthma control is associated with increased risk of exacerbations, impaired quality of life, increased healthcare utilisation and reduced productivity.[11] Research indicates that many patients make errors with their inhalers and this is associated with poor asthma control and increased exacerbations.[2] Ongoing training may help to reduce critical errors.[2]

Mundipharma has listened to patients and doctors to understand the day-to-day challenges of managing asthma. Our drug delivery expertise and approach to provide a range of patient focused solutions is aimed at helping to improve outcomes and enable people with asthma to breathe better.

Notes to editors:  

For further information please visit: 

https://www.mundipharma.com/media/media-libraries/

http://www.flutiform.com/medical-media

About the Mundipharma network:

The Mundipharma global network of privately-owned independent associated companies was founded in 1956 by doctors, and now operates in over 120 countries worldwide. We are focused on developing business partnerships to identify and accelerate meaningful technology across an increasingly diverse portfolio of therapy areas including respiratory, oncology, pain, and biosimilars. Consistent with our entrepreneurial heritage, we like to think we see what others don't by challenging conventional wisdom and asking different and challenging questions. By working in partnership with all our stakeholders, the Mundipharma network develops medicines that create value for patients, payers and wider healthcare systems.

For more information please visit:http://www.mundipharma.com.

About flutiform k-haler:

flutiform k-haler is a novel asthma treatment for adults and adolescents (aged 12 years and older) where the use of a combination product (inhaled corticosteroid [ICS] and long-acting β2-agonist [LABA]) is appropriate.[ 1 ] It is a unique breath-triggered inhaler utilising a patented "kinked" valve - the k-valve™. The device is activated with a low inspiratory force, which is designed to make it easier for patients to use correctly, including those who may find other devices challenging. The k-haler device's patented technology has the potential to be suitable for a range of inhaled products.

About asthma:

Asthma is a chronic inflammatory disorder of the airways which leads to recurrent episodes of wheezing, breathlessness, chest tightness and coughing. Patients with poorly managed asthma are at an increased risk of exacerbations, hospitalisation and death. Poorly managed asthma can also have a huge impact on a person's quality of life and day-to-day activities.[12]

® FLUTIFORM is a registered trade mark of Jagotec AG and is used under licence

® K-HALER is a registered trade mark of Mundipharma

™ K-VALVE is a trade mark of Mundipharma

References: 

1. flutiform k-haler Summary of Product Characteristics 

2. Price D, et al. "Inhaler errors in the CRITIKAL Study: type, frequency and association with asthma outcomes." Journal of Allergy and Clinical Immunology: In Practice. 2017 DOI: http://dx.doi.org/10.1016/j.jaip.2017.01.004 

3. A' Design Award & Competition. K-Haler Inhaler. Available at: https://competition.adesignaward.com/design.php?ID=61400 Last accessed August 2018 

4. Bodzenta-Lukaszyk A, R Buhl, et al. Fluticasone/formoterol combined in a single aerosol inhaler vs budesonide/formoterol for the treatment of asthma: a non-inferiority trial. Eur Respir J 2011a;38:153s  

5. Bodzenta-Lukaszyk A, Dymek A et al. Fluticasone/formoterol combination therapy is as effective as fluticasone/salmeterol in the treatment of asthma, but has a more rapid onset of action: an open-label, randomized study. BMC Pulm Med J. 2011;11:28  

6. Bodzenta-Lukaszyk A, Pulka et al. Efficacy and safety of fluticasone and formoterol. Respir Med J. 2011;105(5):674-82 

7. Backer V, et al. Real-world study to evaluate the safety and effectiveness of fluticasone propionate/formoterol (FP/FORM) in patients with asthma. Abstract FLT9503, European Respiratory Society (ERS) 2017, Milan 

8. Kappeler D, et al. Lung deposition of fluticasone propionate/formoterol administered via a breath-triggered inhaler. Resp Med 138 (2018) 107-114 

9. Bell D, L Mansfield, M Lomax. A Randomized, Crossover Trial Evaluating Patient Handling, Preference, and Ease of Use of the Fluticasone Propionate/Formoterol Breath-Triggered Inhaler. J Aerosol Med Pulm Drug Deliv 2017a;30(6):425-34. 

10. European Respiratory Society. The European Lung White Book. 2013 

11. Price D, et al. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. npj Primary Care Respiratory Medicine 2014. doi:10.1038/npjpcrm.2014.9 

12. Raimundo K, et al. Relationships between asthma control, productivity and health outcomes in a US survey. European Resp J 2016 48: PA4219; DOI: 10.1183/13993003.congress-2016.PA4219


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