FDA approves Spiriva Handihaler for treatment of COPD

INGELHEIM, GERMANY and RIDGEFIELD, CT., February 2, 2004 -- Boehringer Ingelheim Pharmaceuticals announced that the 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 U.S. with Pfizer Inc.

Spiriva, a novel inhaled 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 E. Doherty, MD, chairman of the National Lung Health Education Program and professor of medicine and chief of the Division of Pulmonary and Critical Care Medicine at the University of Kentucky Medical Center.  "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."

In clinical trials, Spiriva demonstrated significant bronchodilation that was sustained over the duration of the studies.5,6,7  In trials, Spiriva demonstrated significant improvements in lung function over Atrovent (ipratropium bromide), a current first-line therapy for COPD, which were maintained over one year.6,7   In addition, in one-year, placebo-controlled studies, patients treated with Spiriva required fewer doses of rescue medications.5  Clinical studies both ongoing and completed include more than 9,400 patients.

Spiriva was generally well tolerated. The most common adverse reaction patients reported in Spiriva clinical trials was dry mouth, which was usually mild and often resolved during treatment. Constipation and increased heart rate have been reported infrequently in patients receiving tiotropium.  As an anticholinergic drug, Spiriva must be used with caution in patients with glaucoma and prostatic hyperplasia, as it may worsen symptoms of these conditions. 

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

Source: Boehringer Ingelheim www.boehringer-ingelheim.com

Latest Pharma Industry News...

Daily MedNews
Pharma Industry News
New Drug Applications
New Drug Approvals
Clinical Trial Results
Generic Drug Approvals