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]
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 delivering fluticasone
propionate/formoterol to the lungs, achieving
high levels of lung deposition in patients with
asthma. If approved, flutiform k-haler would offer a
new device choice for certain patients with
asthma."
Notes to editors:
For further information please visit:
http://www.mundipharma.com/Press/RespiratoryResources/background
http://www.flutiform.com/medical-media/resource-centre
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 pMDI
In Europe, flutiform pMDI is
licensed for the regular treatment of asthma when use of a
combination product (an inhaled corticosteroid [ICS] and a
long-acting β2-agonist [LABA]) is appropriate: for patients not
adequately controlled with an ICS and an 'as required' inhaled
short-acting β2-agonist or for patients already adequately
controlled on both an ICS and a LABA. It is available in countries
across Europe including the UK,
Germany, France, Spain, Netherlands and Italy. flutiform pMDI is available in
50/5μg and 125/5μg strengths for adults and adolescents; 250/10μg
strength for adults only.[8]
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.[9]
About Gamma Scintigraphy
Gamma scintigraphy is an imaging technique using radioisotopes
attached to drugs that travel to a specific organ or tissue and the
emitted gamma radiation is captured by external detectors.
This enables the direct visualisation and quantification of
events occurring in vivo, in real time.
About Vectura
Vectura, a FTSE250 company listed on the London Stock Exchange
(LSE: VEC), is an industry-leading device and formulation business
for inhaled airways products offering a uniquely integrated inhaled
drug delivery platform. With its extensive range of device
and formulation technologies, integrated capabilities and
collaborations, Vectura is a leader in the development of
inhalation products, increasing its ability to help patients
suffering from respiratory diseases.
Vectura has eight inhaled, four non-inhaled and ten oral
products marketed by partners with growing global royalty streams.
The group has a diverse portfolio of drugs in clinical
development, including a number of novel and generic programmes
which are partnered with several global pharmaceutical and
biotechnology companies including Hikma, Novartis, Sandoz,
Mundipharma, Kyorin, Baxter, GSK, UCB, Ablynx, Grifols, Bayer,
Chiesi, Almirall, Janssen, Dynavax and Tianjin KingYork along with
two wholly owned nebulised development programmes.
References:
1. Al-Jahdali H, Ahmed A, Al-Harbi A, Khan M, Baharoon S,
Bin Salih S, et al. Improper inhaler technique is associated
with poor asthma control and frequent emergency department visits.
Allergy Asthma Clin Immunol. 2013;9(1):8.
2. Baddar S, Jayakrishnan B, Al-Rawas OA. Asthma control:
importance of compliance and inhaler technique assessments. J
Asthma. 2014;51(4):429-34.
3. 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;5(4):1071-1081
4. Kappeler D, et al. Lung deposition of fluticasone
propionate/formoterol administered via a breath-triggered inhaler.
Abstract presented at European Respiratory Society (ERS) annual
congress, Milan, Italy 2017
September 9- 13 [PA522]
5. Tuohy J, et al. Plume spray force of three
HFA-propelled ICS/LABA combination inhalers. Abstract presented at
European Respiratory Society (ERS) annual congress, Milan, Italy 2017 September 9- 13 [PA524]
6. Bell D et al. Relative pulmonary bioavailability (BA) of
fluticasone propionate/formoterol (FP/FORM) via pressurised
metered-dose inhaler (pMDI) and a novel breath triggered inhaler
(BTI). Abstract presented at European Respiratory Society (ERS)
annual congress, Milan, Italy 2017
September 9- 13 [PA523]
7. Bell D et al . Systemic bioavailability (BA) and
pharmacodynamics (PD) of fluticasone propionate/formoterol
(FP/FORM) via pressurised metered-dose inhaler (pMDI) or a novel
breath-triggered inhaler (BTI). Abstract presented at European
Respiratory Society (ERS) annual congress, Milan, Italy 2017 September 9- 13 [PA3950]
8. flutiform SmPC
9. European Respiratory Society. The European Lung White Book.
2013. Available at: http://www.erswhitebook.org/
Job code: MINT/RESP-17014
Date of preparation: September
2017