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flutiform® k-haler®, a Novel Treatment for Adolescents and Adults with Asthma, now Available in Europe


CAMBRIDGE, 10 September 2018 – The Mundipharma network of independent associated companies today announces that flutiform k-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 flutiform k-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. flutiform k-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. 


k-haler is an award-winning[3] breath-triggered aerosol device utilising a patented ‘kinked’ valve – the k-valveTM 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. flutiform k-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 launch is 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 errors which is associated with poor asthma control and increased exacerbations. This simple breath-triggered inhaler has been designed with patients in mind, requiring only a gentle inhalation to trigger the dose release, with the aim to help patients reduce critical errors and improve 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, flutiform k-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.

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Last Updated: 11-Sep-2018