Boehringer Ingelheim Pharmaceuticals, Inc. announced that the United States Food and Drug Administration (FDA) has approved Spiriva HandiHaler (tiotropium bromide inhalation powder) for the long-term, once-daily maintenance treatment of bronchospasm associated with Chronic Obstructive Pulmonary Disease (COPD).

COPD, which includes chronic bronchitis and emphysema, is a lung disease primarily caused by smoking. Spiriva was discovered and developed by Boehringer Ingelheim and will be co-promoted in the US with Pfizer Inc.

Spiriva, a novel anticholinergic medication, is the first inhaled treatment to provide significant and sustained improvements in lung function with once-daily dosing. Spiriva works through targeting of the primary reversible component of COPD-constriction of the airways. Spiriva helps COPD patients breathe easier by opening narrowed airways and helping to keep them open for 24 hours. According to treatment guidelines of the Global Initiative for Chronic Obstructive Lung Disease (GOLD), long-acting bronchodilators such as Spiriva are the preferred treatment option for COPD maintenance therapy.

"Spiriva provides significant improvements in key measures of lung function and represents a major advance in the treatment of all stages of COPD," said Dennis Doherty, chairman of the National Lung Health Education Program. "Spiriva will become a first-line maintenance treatment for patients with mild to severe COPD. Patients may be able to control their symptoms for a full 24 hours with scheduled once-a-day use of Spiriva, allowing them to breathe easier, reduce their reliance on rescue medications and help them achieve a more normal lifestyle."

It is anticipated that Spiriva will be available in retail pharmacies by the middle of this year.

COPD is a slowly progressive disease of the airways that is characterized by a gradual loss of lung function. The signs and symptoms patients may experience are chronic cough, excess mucus production, wheezing and shortness of breath after mild exertion. Most people with COPD are at least 40 years old or around middle age when symptoms start.

There are an estimated 24 million Americans who suffer from COPD, with over 50 per cent under the age of 65. However, only 10 million have been diagnosed with the illness and approximately 6 million currently are receiving therapy. COPD is the fourth leading cause of death in the United States and is projected to become the third leading fatal illness by 2020.