RIDGEFIELD, Conn., May 23 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. announced today the availability of Atrovent(R) HFA (ipratropium bromide HFA) Inhalation Aerosol, indicated as a bronchodilator for maintenance treatment of bronchospasm associated with COPD (chronic obstructive pulmonary disease), including chronic bronchitis and emphysema. ATROVENT HFA is not intended for rescue use.
Shipments of ATROVENT HFA will begin arriving at pharmacies across the United States over the next several weeks, so physicians are now able to prescribe the new product to their COPD patients.
ATROVENT HFA is a formulation that was developed to provide patients a therapeutic benefit comparable to the existing chlorofluorocarbon (CFC) version of Atrovent(R) (ipratropium bromide) Inhalation Aerosol, a leading treatment for COPD. The product was developed in accordance with the Montreal Protocol, which calls for the gradual elimination of all CFC-propelled metered-dose inhalation drug products. ATROVENT CFC will no longer be available after December 2005.
"Boehringer Ingelheim is committed to the research and development of replacement products for our CFC-based inhalers," said Steven Kesten, M.D, Therapeutic Director of Clinical & Scientific Affairs for Boehringer Ingelheim Pharmaceuticals, Inc. "Worldwide, we have more than 200 scientists working in 35 different laboratories and have invested close to $400 million in the reformulation of our metered dose inhaler products, including ATROVENT and COMBIVENT."
ATROVENT HFA Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to ipratropium bromide or other ATROVENT HFA Inhalation Aerosol components. ATROVENT HFA Inhalation Aerosol is also contraindicated in patients who are hypersensitive to atropine or its derivatives.
The most common drug-related adverse events were dry mouth (1.6% of ATROVENT HFA Inhalation Aerosol and 0.9% of ATROVENT Inhalation Aerosol CFC patients), and taste perversion (bitter taste) (0.9% ATROVENT HFA Inhalation Aerosol and 0.3% of ATROVENT Inhalation Aerosol CFC patients).
Over the past 50 years, Boehringer Ingelheim has made a dedicated commitment to the research and development of treatments for COPD. In June of 2004, the company launched Spiriva(R) HandiHaler(R) (tiotropium bromide inhalation powder), the first once-daily inhaled medication to provide significant and sustained improvements in lung function for patients with COPD. SPIRIVA is available in a propellant-free dry-powder in a capsule formulation for inhalation.
"With the heavy burden of COPD across the world, there is a tremendous need for medications to treat this respiratory disease," said Dr. William C. Bailey, director of the Lung Health Center, professor of medicine and eminent scholar chair in pulmonary diseases at the University of Alabama-Birmingham. "Boehringer Ingelheim has proven to be the leader in this medical area providing safe and effective medications for the treatment of COPD."
About COPD
COPD is a slowly progressive disease of the airways that is characterized by a loss of lung function over time.(1) The symptoms that patients may experience include chronic cough, excess mucus production, wheezing and shortness of breath even after mild exertion or at rest.(1) COPD is often associated with exacerbations of these symptoms, which can account for a high proportion of healthcare costs associated with this disease.(1) COPD is primarily caused by cigarette smoking.(2) Other causes of the disease include exposure to industrial dusts and chemicals.(2) An estimated 24 million adults in the United States have COPD, but only about 10 million have been diagnosed. Globally, this disabling disease is the fourth leading cause of death, claiming more than 2.7 million lives annually.(2)
About ATROVENT Inhalation Aerosol and COMBIVENT(R) (ipratropium bromide
and albuterol sulfate) Inhalation Aerosol
ATROVENT is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema. COMBIVENT is indicated for use in patients with COPD on a regular aerosol bronchodilator who continue to have evidence of bronchospasm requiring a second bronchodilator. Neither ATROVENT or COMBIVENT are intended for use as rescue medication. ATROVENT and COMBIVENT are contraindicated in patients with a history of hypersensitivity to soya lecithin or related food products, such as soybean and peanut. Use ATROVENT and COMBIVENT with caution in patients with narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction, and in those sensitive to sympathomimetic agents. Use COMBIVENT with caution in patients with convulsive disorders, hyperthyroidism, diabetes mellitus, and with extreme caution in patients taking MAO inhibitors or tricyclic antidepressants. COMBIVENT contains albuterol sulfate, which can produce significant cardiovascular effects and hypokalemia, as well as potential life-threatening paradoxical bronchospasm.
About SPIRIVA
SPIRIVA is indicated for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. SPIRIVA is not indicated for rescue therapy and is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives or to any component of this product. The most common adverse reaction was dry mouth, which was usually mild and often resolved during treatment.(3) Other reactions reported in individual patients and consistent with possible anticholinergic effects included constipation, increased heart rate, blurred vision, glaucoma, urinary difficulty, and urinary retention. Please see http://www.spiriva.com/ for full prescribing information.
Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 144 affiliates in 45 countries and nearly 36,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2004, Boehringer Ingelheim posted net sales of US $10.2 billion (8.2 billion euro) while spending nearly one fifth of net sales in its largest business segment, Prescription Medicines, on research and development.
For more information, please visit http://us.boehringer-ingelheim.com/.
(1) National Heart, Lung, and Blood Institute. Data Fact Sheet: Chronic
Obstructive Pulmonary Disease (COPD).
(2) World Health Organization. World health report 2003. Statistical
Annex. Annex table 2: 154-159.
(3) Spiriva HandiHaler (tiotropium bromide inhalation powder) Prescribing
Information. Boehringer Ingelheim and Pfizer 2004. Available at
http://www.spiriva.com/.
Boehringer Ingelheim Pharmaceuticals, Inc.