New data Presented at ERS 2017 on flutiform® k-haler®(fluticasone propionate and formoterol), Mundipharma's Novel Breath-triggered Aerosol Inhaler

CAMBRIDGE, England, September 10, 2017 /PRNewswire/ --

• flutiform k-haler achieved high levels of lung deposition of over 44% of delivered dose
• Plume force of flutiform k-haler was compared with fluticasone propionate/salmeterol xinafoate delivered via the Seretide^® Evohaler^® pMDI and Sirdupla^® pMDI devices
• Pharmacokinetic studies show efficacy and safety profile of new flutiform k-haler device would be comparable to flutiform pMDI device

Mundipharma today announced new data from four studies demonstrating efficient drug delivery characteristics with flutiform^® k-haler^®, a novel, breath-triggered inhaler, currently in development.  

The efficacy of inhaled asthma treatments is dependent on adequate deposition of the drug in the lungs.  Poor or improper inhaler technique in asthma patients can lead to critical inhaler errors and is associated with reduced disease control,^[1],[2] worse asthma outcomes^[3] and an increase in hospital visits, compared to patients with good inhaler technique.^[1]

The flutiform k-haler takes its name from a unique kinked valve which removes the need for co-ordination, with only gentle inhalation required to trigger the aerosol.

Details of the four flutiform k-haler presentations 

The first study examined the pulmonary deposition of the flutiform k-haler device (125/5 microgram) using gamma scintigraphy and showed that in patients with asthma, high levels of lung deposition of over 44% of the delivered dose were achieved.^[4]

A second in vitro study compared the plume force of flutiform k-haler 125/5µg with fluticasone propionate/salmeterol xinafoate 125/25µg (FP/SAL) from the Seretide^® Evohaler^® pMDI; and 125/25µg FP/SAL from the Sirdupla^® pMDI over distances of 25-95mm. 60-95mm represents the typical distance between the inhaler and back of the throat. ^[5] Plume characteristics of aerosol devices may affect drug delivery to the lungs and impaction at the back of the throat.^[5]

The final two single dose, cross-over pharmacokinetic studies assessed how pulmonary bioavailability and systemic exposure of fluticasone propionate and formoterol 125/5µg of flutiform k-haler compared to Mundipharma's existing flutiform pMDI device when administered in healthy adults with or without a spacer. These data suggest that the efficacy (based on pulmonary bioavailability) and safety (based on total systemic exposure) profile of the new device would be comparable to the registered flutiform pMDI device. ^[6],^[7]