FDA approves Spiriva Respimat for COPD - Boehringer

The FDA has approved Spiriva Respimat (tiotropium bromide) inhalation spray, from Boehringer, for the long-term, once-daily maintenance treatment of bronchospasm associated with Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and emphysema and to reduce exacerbations in COPD patients. Boehringer Ingelheim anticipates Spiriva Respimat to be available in January 2015.

The approval of Spiriva Respimat is based on data from seven clinical trials in which 8,700 patients were treated with Spiriva Respimat. One of these trials, TIOSPIR, the largest clinical trial conducted to date in patients with COPD, collected data from more than 5,700 patients treated with Spiriva Respimat and nearly 5,700 patients treated with Spiriva HandiHaler.

The most common side effects reported with Spiriva Respimat include sore throat, cough, dry mouth and sinus infection.