Boehringer Ingelheim announced that the Food and Drug Administration (FDA) has approved Spiriva Respimat (tiotropium bromide) inhalation spray for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD).
Spiriva Respimat delivers a pre-measured dose in a slow-moving mist independent of how fast air is breathed in from the inhaler. The Respimat inhaler uses mechanical energy to generate the slow-moving mist. Spiriva Respimat formulation contains the same ingredient as Spiriva HandiHaler (tiotropium bromide inhalation powder).
The approval of Spiriva Respimat was based on data from 7 clinical trials in which 8,700 patients were treated with Spiriva Respimat. One of these trials, TIOSPIR, collected data from more than 5,700 patients treated with Spiriva Respimat and nearly 5,700 patients treated with Spiriva HandiHaler.
Spiriva Respimat is expected to be available in January 2015 as a carton containing one cartridge and one Respimat inhaler (60 metered actuations). Each actuation delivers 2.5mcg tiotropium (equivalent to 3.124mcg tiotropium bromide monohydrate). Spiriva HandiHaler will continue to be available.
For more information call (800) 542-6257 or visit US.Boehringer-Ingelheim.com.