Boehringer Ingelheim Launches Combivent® Respimat® (ipratropium bromide and albuterol) Inhalation Spray for Chronic Obstructive Pulmonary Disease

RIDGEFIELD, Conn., Sept. 18, 2012 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. announced today that COMBIVENT RESPIMAT is now available by prescription in the United States. COMBIVENT RESPIMAT is a unique, propellant-free inhaler that uses a slow-moving mist to deliver the same active ingredients as COMBIVENT Inhalation Aerosol, which is delivered in a metered dose inhaler (COMBIVENT MDI).

COMBIVENT RESPIMAT is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.

COMBIVENT RESPIMAT requires one inhalation per dose as compared to COMBIVENT MDI, which requires two inhalations per dose. COMBIVENT RESPIMAT offers a dose indicator to inform patients of the amount of remaining medication in the inhaler, and the device locks when all of the medication has been used. When used as directed, each COMBIVENT RESPIMAT delivers 30 days worth of treatment compared to 25 days worth of treatment in each COMBIVENT MDI, so COMBIVENT RESPIMAT patients may require two less inhalers over the course of a year.

"COMBIVENT RESPIMAT is a testament to our company's commitment to developing advancements for people living with respiratory disease," said Tunde Otulana, M.D., vice president, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. "We are continuing to examine the potential of several late-stage investigational compounds also delivered by the RESPIMAT inhaler."

COMBIVENT RESPIMAT was developed in response to the Montreal Protocol, an international treaty requiring the phase-out of inhalers that use chlorofluorocarbons (CFCs) as propellants, such as COMBIVENT MDI. COMBIVENT RESPIMAT uses a spring mechanism to release the medication, rather than a propellant, so it does not release CFCs.

COMBIVENT RESPIMAT is now available to patients by prescription, and to allow adequate time to transition, COMBIVENT MDI will be available until mid-2013. As of July 2013, COMBIVENT RESPIMAT will be the only COMBIVENT product available.

"COMBIVENT RESPIMAT offers patients the same active ingredients of COMBIVENT MDI in a new propellant-free inhaler. Other noteworthy features include a new dosing indicator and locking mechanism to inform patients that all of the medication has been used," said Dennis E. Doherty, M.D., professor of medicine, Division of Pulmonary, Critical Care and Sleep Medicine, University of Kentucky. "To support patients during this transition period, Boehringer Ingelheim has developed training tools and educational resources to ensure that both healthcare professionals and patients are properly trained and understand how to use this new type of inhaler."

COMBIVENT MDI and COMBIVENT RESPIMAT are the only short-acting bronchodilator products that offer two different medicines in a single inhaler. Clinical studies in patients with COPD have shown that the combination of ipratropium bromide and albuterol sulfate provides patients significantly greater improvement in lung function than either component alone.

In a 12-week, randomized, double-blind, placebo- and active-controlled clinical trial, COMBIVENT RESPIMAT was shown to be clinically comparable to COMBIVENT MDI, in terms of FEV₁. FEV₁ is the maximal amount of air that can be forcefully exhaled in one second. In the study, treatment was administered to patients with COPD four times a day.

About COPD
Chronic obstructive pulmonary disease (COPD) is a term including chronic bronchitis and/or emphysema. This disease makes it harder to breathe because less air is able to flow in and out of the lungs. More than 26 million Americans may have COPD – even those who haven't smoked in years – and half of them remain undiagnosed. COPD is the fourth leading cause of death in the United States. It kills one person every four minutes and more people each year than breast cancer and diabetes combined.

Common symptoms of COPD include coughing, with or without mucus production, or shortness of breath. These symptoms are often confused with normal signs of aging. As COPD progresses, symptoms tend to get worse and more damage occurs in the lungs. Breathing gradually becomes more difficult until people with COPD feel like they are inhaling and exhaling through a small straw.

About COMBIVENT (ipratropium bromide and albuterol sulfate) Inhalation Aerosol (MDI) and COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray

COMBIVENT Inhalation Aerosol and COMBIVENT RESPIMAT are indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.

Important Safety Information About COMBIVENT Inhalation Aerosol and COMBIVENT RESPIMAT

COMBIVENT Inhalation Aerosol and COMBIVENT RESPIMAT are contraindicated in patients hypersensitive to any of the ingredients of the drug product or to atropine or its derivatives. COMBIVENT Inhalation Aerosol is also contraindicated in patients with a history of hypersensitivity to soya lecithin or related food products such as soybean and peanut.

COMBIVENT can produce paradoxical bronchospasm that can be life-threatening. If it occurs, therapy with COMBIVENT should be discontinued immediately and alternative therapy instituted.

The albuterol sulfate contained in COMBIVENT can produce a clinically significant cardiovascular effect in some patients. If cardiovascular symptoms occur, COMBIVENT may need to be discontinued.

COMBIVENT should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

COMBIVENT contains ipratropium bromide and may increase intraocular pressure which may result in precipitation or worsening of narrow-angle glaucoma.

Patients should avoid spraying the aerosol into their eyes as this may cause acute eye pain or discomfort, temporary blurring of vision, mydriasis, visual halos, or colored images in association with red eyes from conjuctival or corneal congestion. Advise patients to consult their physician immediately if any of these symptoms develop while using COMBIVENT.

Ipratropium bromide also may cause urinary retention.

COMBIVENT should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction.

Since dizziness and blurred vision may occur with the use of COMBIVENT, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery.

Do not exceed recommended dose. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma.

Hypersensitivity reactions including urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema may occur. If such a reaction occurs, therapy with COMBIVENT should be stopped at once and alternative treatment should be considered.

COMBIVENT contains albuterol and should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus, and in patients who are unusually responsive to sympathomimetic amines. Albuterol may produce significant hypokalemia in some patients.

In clinical trials, the most common adverse reactions reported for COMBIVENT were bronchitis, upper respiratory tract infection, headache, dyspnea, cough, pain, respiratory disorder, sinusitis, pharyngitis, nausea, and nasopharyngitis.

COMBIVENT may interact additively with concomitantly used anticholinergic medications. Avoid co-administration with other anticholinergic-containing drugs.

Caution is advised in co-administration of other beta-adrenergic agents, beta-receptor blocking agents, and non-potassium sparing diuretics. Extreme caution is advised with monoamine oxidase inhibitors or tricyclic antidepressants.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For full prescribing information for COMBIVENT RESPIMAT, please visit www.Combivent.com.

For full prescribing information for COMBIVENT MDI, please visit www.Combivent.com.

Leading Respiratory Forward
Through research, treatments and patient-centric support services, the Boehringer Ingelheim (BI) lung health portfolio is designed to help address the challenges people living with a lung disease face every day. Leveraging the company's cutting edge science and leadership in chronic obstructive pulmonary disease (COPD), BI is researching new treatment approaches where needs persist. It is the company's goal to make a difference in the lives of patients with COPD, asthma, lung cancer, idiopathic pulmonary fibrosis and other respiratory diseases.

About 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 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act in a socially responsible manner. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.

In 2011, Boehringer Ingelheim achieved net sales of about $17.1 billion (13.2 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 23.5 percent of its net sales. 

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.

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