New combination inhaler launched for the regular maintenance treatment of asthma fluticasone/formoterol combination inhaler (flutiform®), offers a new combination treatment option for asthma symptom control and potential for NHS savings
Cambridge, UK, Tuesday 25 September 2012 – A new inhaled combination medicine for asthma patients, fluticasone/formoterol combination inhaler (flutiform), is available in the UK from today to be prescribed to appropriate asthma patients, with the two lower doses available for adults and adolescents aged 12 years and older and the highest dose for adults aged 18 years and older. This is the first time that fluticasone propionate (fluticasone), an inhaled corticosteroid (ICS) and formoterol fumarate (formoterol), a long-acting ß2-agonist (LABA) have been combined in a single inhaler.1
As well as providing an alternative combination treatment for patients with asthma, the combination inhaler is also a cost-effective treatment for asthma, with the lower strength (50/5 µg) currently at price parity and the two higher strengths (125/5 µg and 250/10 µg) currently at a lower cost than the fluticasone/salmeterol MDI.2,3
Additionally, it has been calculated that by switching appropriate patients to the fluticasone/formoterol combination inhaler from the fluticasone/salmeterol MDI, it is possible to achieve drug cost savings for the NHS.1,4
"There are 5.4 million people in the UK living with asthma. Many people with asthma are not optimally controlled remain at risk of exacerbations with the consequence of reduced quality of life and increased healthcare costs. So advances in medication and a new combination treatment option is very much welcomed," said Professor David Price, GP with special interest in respiratory disease and Primary Care Respiratory Society UK, Professor of Primary Care Respiratory Medicine, University of Aberdeen. "This new combination treatment consists of two medicines which most doctors are familiar with. In combining both fluticasone and formoterol in one inhaler, doctors now have a new alternative combination treatment which may help some patients better manage their condition." The 50/5 µg and 125/5 µg per actuation strengths of the fluticasone/formoterol combination inhaler are indicated for the regular treatment of asthma in adults and adolescents aged 12 years and over and the 250/10 µg per actuation strength is only indicated for adult patients aged 18 years and over, where the use of a combination product is appropriate.1 The fluticasone/formoterol combination inhaler is indicated for patients not adequately controlled with ICS and 'as required' inhaled short-acting ß2-agonist (SABA), or for patients already adequately controlled on both an ICS and a LABA.1
In Phase III trials, the fluticasone/formoterol combination showed comparable results in delivering efficacy and safety compared with its individual components administered concurrently via two separate inhalers.5 The combination also demonstrated non-inferior efficacy compared with two of the most widely prescribed combination treatments in Europe, fluticasone/salmeterol (P = 0.007; open label) and budesonide/formoterol (P <0.001) and comparable safety profiles. 6,7
"Significant technical hurdles were overcome in developing the new combination which reinforces our ambition and commitment to provide healthcare professionals with more treatment choices and strengthens our heritage in the respiratory area. Napp is committed to support GPs and other healthcare professionals in achieving the highest standards of care for patients with asthma and is pleased to introduce this alternative combination treatment option for patients in the UK," said Dr Paul Schofield, Medical Director, Napp Pharmaceuticals Limited.
1. flutiform® SPC, Napp Pharmaceuticals Limited
2. Napp Pharmaceuticals Limited. Data on file. flutiform® cost effectiveness analysis.
3. MIMS. August 2012.
4. Cegedim Strategic Data. Patient Data Report Respiratory Market (NAP_R3_001. DN2). March 2012.
5. Bodzenta-Lukaszyk A, van Noord JA, Schroder-Babo W, et al. Fluticasone propionate/formoterol fumarate combination therapy has comparable efficacy to its individual components administered concurrently. Abstract presented at the European Respiratory Society Annual Congress; 2011 Sep 24-28; Amsterdam, Netherlands.
6. Bodzenta-Lukaszyk A, Dymek A, McAulay K, 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 2011; 11:28.
7. Bodzenta-Lukaszyk A, Buhl R, Balint B, et al. Fluticasone/formoterol combined in a single aerosol inhaler vs budesonide/formoterol for the treatment of asthma: a non-inferiority trial. Abstract presented at the European Respiratory Society Annual Congress. 2011; Sep 24-28; Amsterdam, Netherlands.
8. Department of Health. An Outcomes Strategy for Chronic Obstructive Pulmonary Disease (COPD) and Asthma in England, 2011. [Accessed July 2012] available at http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_127974.
9. Bodzenta-Lukaszyk A, Pulka G, Dymek A, et al. Efficacy and safety of fluticasone propionate and formoterol fumarate in a single pressurized metered dose inhaler. Respiratory Medicine 2011; 105(5):674-682.
10. Pearlman DS, LaForce CF, Kaiser K, et al. Fluticasone propionate/formoterol fumarate combination therapy has superior efficacy to both fluticasone and formoterol alone. Abstract presented at the European Respiratory Society Annual Congress. 2011; Sep 24-28; Amsterdam, Netherlands.
11. Nathan RA, D'Urzo AD, Kaiser K, et al. Twice-Daily Fluticasone Propionate (FP)/Formoterol Fumarate (FM) HFA pMDI Combination Therapy is Safe, Efficacious, and Reduces Asthma Exacerbations in Patients With Mild to Moderate Asthma. Abstract presented at the American Thoracic Society Meeting. May 15-20, 2009, San Diego, California. Am J Resp Crit Care Med 179;2009:A2786.
12. Pearlman D, LaForce C, Kaiser K, et al. A Safety and Efficacy Evaluation of Twice-Daily Fluticasone Propionate and Formoterol Fumarate Combination in a Single Inhaler in Patients with Mild to Moderate Asthma. Abstract presented at the 2009 CHEST meeting. October 31 - November 4, 2009, San Diego, CA.
13. Corren J, Mansfield L, Kaiser K, et al. Twice-daily fluticasone propionate (FP)/formoterol fumarate (FM) HFA pMDI combination therapy is safe, efficacious, and reduces asthma exacerbations in patients with moderate to severe asthma. Abstract presented at the American Thoracic Society meeting. May 15-20, 2009, San Diego, California.
14. Corren J, Mansfield L, Kaiser K, et al. Efficacy of twice-daily fluticasone propionate and formoterol fumarate combination administered using an HFA pMDI in patients with moderate to severe asthma. Abstract presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Congress. March 13-17, 2009; Washington, DC.