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

Cambridge, England (ots/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]

Jonathan Marshall, Head of Medical Insights, Mundipharma
International Limited commented: "The studies presented at this
year's ERS conference demonstrate how effective the k-haler is at