Boehringer Ingelheim and Pfizer

New SPIRIVA(R) Respimat(R) Inhaler Completes European Approval Process for COPD

Ingelheim, Germany (ots/PRNewswire) - - Patients to Benefit From Easy-to-Use Inhaler With Enhanced Drug Delivery Boehringer Ingelheim and Pfizer today announced successful completion of the approval process for authorisation to market SPIRIVA(R) Respimat(R) in the European Union for people with chronic obstructive pulmonary disease (COPD). This positive opinion for the SPIRIVA(R) Respimat(R) is the cornerstone of all national approvals in 25 countries of the European Union. SPIRIVA(R) Respimat(R) is a propellant-free, new generation inhaler that combines innovative technology with the proven efficacy of SPIRIVA(R) (tiotropium).(1) "SPIRIVA(R) Respimat(R) represents a major step forward in COPD and inhalation therapy. Many patients find certain inhaler devices difficult to coordinate and use," said Professor Marc Decramer, Respiratory Division, University Hospitals, Katholieke Universiteit Leuven, Belgium. "SPIRIVA(R) Respimat(R) has a unique and sophisticated delivery system, and a user friendly design, making it easy to use and suitable for a broad range of patients with COPD. In addition the long-lasting, soft mist cloud generated by SPIRIVA(R) Respimat(R) ensures optimised delivery of SPIRIVA(R) to the lungs, helping patients breathe more easily," he added. In clinical studies comparing inhaler devices,(1) patients preferred Respimat(R) Soft Mist(TM) Inhaler, which may help increase patient compliance with therapy.(2),(3),(4),(5) The novel dose-delivery system of the SPIRIVA(R) Respimat(R) also means that unlike dry powder inhalers, the dose delivered is not dependent on patients' inspiratory flow. SPIRIVA(R) (tiotropium), a first-line maintenance therapy for COPD, positively impacts the clinical course of the disease, helping to change the way patients live with their condition.(6),(7) The efficacy of SPIRIVA(R) has been demonstrated by an extensive clinical development programme, which has treated over 25,000 patients.(1) It is the most prescribed brand in COPD in the world.(8) The SPIRIVA(R) Respimat(R) delivery system relies on energy released from a spring, rather than propellants, to produce a long-lasting, slow moving Soft Mist(TM). The innovative design makes SPIRIVA(R) Respimat(R) easy to use, and the Soft Mist(TM) results in improved delivery of SPIRIVA(R) to the lungs, with reduced deposition in the mouth and throat compared to a pressurised metered dose inhaler (pMDI). One study showed that 72% of all patients use pMDIs incorrectly and almost half (47%) have problems with coordinating use of the device.(9) 600 million people worldwide live with COPD and its prevalence is predicted to rise making it the world's third leading cause of death by 2020.(10),(11) It is estimated that up to 50% of Americans and 75% of Europeans with COPD are undiagnosed.(12),(13) Dosing SPIRIVA(R) Respimat(R) 2.5 microgram (total 5 microgram dose administered as 2 x 2.5 microgram puffs) has a therapeutic effect comparable to SPIRIVA(R) HandiHaler(R) 18 microgram.(14) SPIRIVA(R) Respimat(R) is a convenient, multi-dose device with a dose indicator and can provide treatment for one month. Please be advised This release is from the Corporate Headquarters of Boehringer Ingelheim and Pfizer and is intended for all international markets. This being the case, please be aware that there may be some differences between countries regarding specific medical information including licensed uses. Please take account of this when referring to the material. Notes to Editors Advanced technology; simple operation To use the SPIRIVA(R) Respimat(R) patients simply need to twist the base of the inhaler 180 degrees. This action compresses the spring, which results in a pre-defined, metered volume of solution being drawn up through the capillary tube and into a micro-pump. The Soft Mist(TM) is generated by the use of principles established for microchip technology which enables fine fluid channels to be etched into the surface of silicon wafers. These are then covered by a glass plate and bonded chemically. This filter structure known as a uniblock, results in two extremely fine outlet channels, through which SPIRIVA(R) is forced, producing two ultra fine jets of liquid that converge at a carefully controlled angle. The impact of these two jets converging is what creates the unique Soft Mist(TM). Once the dose-release button is pressed, the energy released from the spring forces the solution through the uniblock and the slow-moving, long-lasting Soft Mist (TM) is released. About SPIRIVA(R) (tiotropium) SPIRIVA(R), a long-acting inhaled anticholinergic medication, is the first inhaled treatment to provide significant and sustained improvements in lung function with once-daily dosing. SPIRIVA(R) positively impacts the clinical course of COPD, helping to change the way patients live with their disease.(6),(7) It is the most prescribed medication for the treatment of COPD in the world.(8) SPIRIVA(R) works through targeting of a dominant reversible mechanism of COPD - cholinergic bronchoconstriction.(15),(16) SPIRIVA(R) helps COPD patients breathe easier by opening narrowed airways and helping to keep them open for 24 hours. The SPIRIVA(R) clinical programme has recruited over 25,000 patients.(1) SPIRIVA(R) has demonstrated significant and sustained bronchodilation (opening of the airways)(7),(16) and reduction in hyperinflation (air trapping).(15),(17) SPIRIVA(R) also demonstrated superior and sustained improvements in lung function (FEV1) over ipratropium bromide (ATROVENT(R)) Inhalation Aerosol, a current first-line therapy for COPD, which were maintained over one year(7) and has also demonstrated superior improvement in key lung function parameters over salmeterol.(18) In addition, in placebo-controlled studies, patients treated with SPIRIVA(R) had less activity-induced breathlessness and improved exercise endurance.(6), (19) They required fewer doses of rescue medications, had fewer exacerbations and COPD-related hospitalizations.(16) In clinical trials, the most common adverse reaction reported with SPIRIVA(R) was dry mouth, which was usually mild and often resolved during treatment. (7), (16) Long-acting bronchodilators, including SPIRIVA(R), are a preferred maintenance therapy for COPD from stage II onwards according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) treatment guidelines.(20) About Boehringer Ingelheim The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 137 affiliates in 47 countries and 38,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine. In 2006, Boehringer Ingelheim posted net sales of 10.6 billion Euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development. For more information please visit About Pfizer Inc Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines for humans and animals, and many of the world's best-known consumer products. For further information on Pfizer, please see Contact: Boehringer Ingelheim GmbH Ute E Schmidt Corporate Division Communications 55216 Ingelheim am Rhein GERMANY Phone: +49-6132-77-97296 Pfizer Inc Francisco Gebauer Corporate Media Relations 235 East 42nd street New, York, NY USA Phone: +1-212-733-5191 Graphics, photos and data for feature articles are available on request. References - (1) Hydrofluoroalkane Metered Dose Inhaler, Turbuhaler(R), Diskus(R) - (1) Data on file. Ingelheim, Germany: Boehringer Ingelheim International GmbH. - (2) Hodder R. Design and interpretation of device preference trials: marketing tools or scientific instruments? Respiratory Drug Delivery. 2006;1:19-36. - (3) Schürmann W, Schmidtmann S, Moroni P, Massey D, Qidan M. Respimat(R) Soft Mist (TM) Inhaler versus hydrofluoroalkane metered dose inhaler: patient preference and satisfaction. Treat Respir Med. 2005;4:53-61. - (4) Hodder R, Reese PR. Asthma patients prefer Respimat(R) Soft Mist(TM) Inhaler to Turbuhaler(R). Presented at: International Society for Aerosols in Medicine (ISAM) 16th Congress; June 16-20, 2007; Tours, France. - (5) Freytag F, Rau-Berger H, Glaab T, Wolf K. Respimat(R) Soft Mist (TM) Inhaler preferred to Diskus by patients with COPD and/or asthma. Presented at: 2007 International Conference of the American Thoracic Society (ATS); May 18-23, 2007; San Francisco, CA. - (6) Casaburi R, Kukafka D, Cooper CB, et al. Improvement in exercise tolerance with the combination of tiotropium and pulmonary rehabilitation in patients with COPD. Chest 2005; 127: 809-817. - (7) Vincken W, van Noord JA, Greefhorst APM, et al. Improved health outcomes in patients with COPD during 1 year's treatment with tiotropium. Eur Respir J 2002; 19: 209-216. - (8) IMS Health, IMS MIDAS(tm), 2Q2005 - (9) Giraud V et al. Misuse of corticosteroid metered-dose inhaler is associated with decreased asthma stability. Eur Respir J.2002;19:246-251 - (10) World Health Organization. World Health Report 2004. Statistical Annex. Annex table 2 and 3: 120-131. - (11) Murray CJL, Lopez AD. eds. The Global Burden of Disease: a comprehensive assessment of mortality and disability from diseases, injuries, and risk factors in 1990 and projected to 2020. Cambridge; Harvard University Press; 1996. - (12) Centers for Disease Control and Prevention. Surveillance Summaries, August 2, 2002. MMWR: 51 (No SS06). - (13) Rudolf M. The reality of drug use in COPD: The European Perspective. Chest 2000; 117(suppl): 29S-32S. - (14) van Noord JA, Cornelissen G, Aumann J-L, Platz J, Mueller A, Fogarty C. Efficacy in COPD patients of tiotropium administered via the Respimat(R) Soft Mist(TM) Inhaler (SMI) compared to HandiHaler(R) (HH) Eur. Respir. J 2006; 28 (suppl 50): 431S - (15) Celli B, ZuWallack R, Wang S, Kesten S. Improvement in resting inspiratory capacity and hyperinflation with tiotropium in COPD patients with increased static lung volumes. Chest. 2003;124:1743-1748. - (16) Casaburi R, Mahler DA, Jones PW, et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur Respir J. 2002;19:217-224. - (17) O'Donnell DE, Fluge T, Gerken F, et al. Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD. Eur Respir J.2004 23(6):832-48 - (18) Brusasco V, Hodder R, Miravitlles M, et al. Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD. Thorax 2003; 58: 399-404. - (19) Maltais F, Hamilton A, Marciniuk D, et al. Improvements in symptom-limited exercise performance over 8 h with once-daily tiotropium in patients with COPD. Chest. 2005;128:1168-1178. - (20) Pocket Guide to COPD diagnosis, management, and prevention - A guide for healthcare professionals. Global Initiative for Chronic Obstructive Lung Disease. Available at: ots Originaltext: Boehringer Ingelheim and Pfizer Im Internet recherchierbar: Contact: Contact: Boehringer Ingelheim GmbH, Ute E Schmidt, Corporate Division Communications, 55216 Ingelheim am Rhein, GERMANY, Phone: +49-6132-77-97296; Pfizer Inc, Francisco Gebauer, Corporate Media Relations, 235 East 42nd street, New, York, NY, USA, Phone: +1-212-733-5191

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