NAPSR News: FDA Approves Mist Version of Spiriva® Respimat®

WASHINGTON - Sept. 26, 2014 - PRLog -- The U.S Food and Drug Administration (FDA) has approved the inhalation mist version of Boehringer Ingelheim’s Spiriva® Respimat®  (tiotropium bromide) to treat bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema and to reduce exacerbations in COPD patients. SPIRIVA RESPIMAT is intended to relax the airways and keep them open and is administered as a once-daily maintenance treatment in the form of a slow moving mist.

"SPIRIVA RESPIMAT offers a new choice between a mist and dry powder inhaler for tiotropium," said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Already approved in 85 countries around the world, SPIRIVA RESPIMAT reflects our scientific heritage as an industry leader in discovering and developing new treatment options for the COPD community."

FDA approval stems from clinical data collected from seven clinical trials in which 8, 700 patients were assessed, this includes the largest COPD clinical trial to date called TIOSPIR™ where 5,700 patients were treated with SPIRIVA RESPIMAT.

COPD, or chronic obstructive pulmonary disease, is a progressive lung disease that makes it hard to breathe. Symptoms associated with COPD include coughing, producing large amounts of mucus, wheezing, shortness of breath. COPD’s known leading cause is that of cigarette smoke or prolonged exposure to cigarette smoke and/or other lung irritants such as air pollution, chemical fumes – even dust. COPD develops slowly and will worsen over time. According to the National Heart, Lung, and Blood Institute, COPD is the third leading cause of death in the United States. There is no known cure for COPD to date. “The availability of this new long-term maintenance medication provides an additional treatment options for the millions of Americans who suffer with COPD,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

SPIRIVA RESPIMAT is expected to  be available by January 2015 according to Boehringer Ingelheim.

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