New Spiriva® Respimat® inhaler completes European approval process for COPD

Boehringer Ingelheim and Pfizer today announced successful completion of the approval process for authorisation to market Spiriva® Respimat® in the European Union for people with chronic obstructive pulmonary disease (COPD). This positive opinion for the Spiriva® Respimat® is the cornerstone of all national approvals in 25 countries of the European Union. Spiriva® Respimat® is a propellant-free, new generation inhaler that combines innovative technology with the proven efficacy of Spiriva® (tiotropium).1

“Spiriva® Respimat® 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® Respimat® 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® Respimat® ensures optimised delivery of Spiriva® to the lungs, helping patients breathe more easily,” he added.

In clinical studies comparing inhaler devices,* patients preferred Respimat® Soft Mist™ Inhaler, which may help increase patient compliance with therapy.2,3,4,5 The novel dose-delivery system of the Spiriva® Respimat® also means that unlike dry powder inhalers, the dose delivered is not dependent on patients’ inspiratory flow.

Spiriva® (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® 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® Respimat® delivery system relies on energy released from a spring, rather than propellants, to produce a long-lasting, slow moving Soft Mist™. The innovative design makes Spiriva® Respimat® easy to use, and the Soft Mist™ results in improved delivery of Spiriva® 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® Respimat® 2.5 microgram (total 5 microgram dose administered as 2 x 2.5 microgram puffs) has a therapeutic effect comparable to Spiriva® HandiHaler® 18 microgram.14 Spiriva® Respimat® 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.