Boehringer Ingelheim Announces FDA Approval of Spiriva® Respimat® (tiotropium bromide) Inhalation Spray for the Maintenance Treatment of COPD

Ridgefield, Conn., September 25, 2014 – Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Spiriva® Respimat® (tiotropium bromide) inhalation spray for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema and to reduce exacerbations in COPD patients. Boehringer Ingelheim anticipates SPIRIVA RESPIMAT to be available in January 2015.

SPIRIVA RESPIMAT provides a pre-measured amount of medicine in a slow-moving mist that helps patients inhale the medicine. SPIRIVA RESPIMAT was developed to actively deliver medication in a way that does not depend of how fast air is breathed in from the inhaler.

SPIRIVA RESPIMAT has the same active ingredient as Spiriva® HandiHaler® (tiotropium bromide inhalation powder), which is the number one branded prescription medication for COPD maintenance in the United States. SPIRIVA HandiHaler will continue to be available as a treatment option.

“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.”

The approval of SPIRIVA RESPIMAT is based on data from seven clinical trials in which 8,700 patients were treated with SPIRIVA RESPIMAT. One of these trials, TIOSPIR™, the largest clinical trial conducted to date in patients with COPD, collected data from more than 5,700 patients treated with SPIRIVA RESPIMAT and nearly 5,700 patients treated with SPIRIVA HandiHaler.

The most common side effects reported with SPIRIVA RESPIMAT include sore throat, cough, dry mouth and sinus infection.

“COPD is a chronic condition that requires highly individualized treatment for optimal disease management. It’s essential to have multiple choices available for healthcare providers and patients,” said Stephen Rennard, M.D., Professor, Internal Medicine, Division of Pulmonary, Critical Care, Sleep & Allergy, University of Nebraska Medical Center. “Each inhaler option has different features that a healthcare provider and patient might decide are more suitable for their specific situation.”

The RESPIMAT is the platform inhaler for the Boehringer Ingelheim suite of inhaled bronchodilators, including approved and investigational therapies. SPIRIVA RESPIMAT is the third FDA-approved product delivered by the RESPIMAT, which is the only inhaler available in the U.S. that uses mechanical energy to generate a slow-moving mist to deliver the medication.

About Spiriva® Respimat® (tiotropium bromide) Inhalation Spray

Indication
SPIRIVA® RESPIMAT® (tiotropium bromide) Inhalation Spray is a prescription medicine used once every day (a maintenance medicine) to relax your airways and help keep them open. COPD includes chronic bronchitis, emphysema, or both. 

SPIRIVA RESPIMAT also reduces the likelihood of COPD flare-ups (COPD exacerbations). 

Important Safety Information for SPIRIVA RESPIMAT 
Do not use SPIRIVA RESPIMAT if you are allergic to tiotropium, ipratropium, or any ingredient in SPIRIVA RESPIMAT. Symptoms of a serious allergic reaction may include swelling of the lips, tongue or throat, itching or rash.

SPIRIVA RESPIMAT is not a rescue medicine and should not be used for treating sudden breathing problems.

Immediate allergic reactions including hives, swelling of the lips, tongue or throat, rash, sudden breathing problems, or itching may occur after taking SPIRIVA RESPIMAT. If this happens, stop taking SPIRIVA RESPIMAT and seek immediate medical help.

If your breathing suddenly gets worse while taking SPIRIVA RESPIMAT, use your rescue medicine. Stop taking SPIRIVA RESPIMAT and seek immediate medical help.

Tell your doctor if you have glaucoma as this may worsen with SPIRIVA RESPIMAT. If you have eye pain, blurred vision or vision changes, stop taking SPIRIVA RESPIMAT and call your doctor right away.

Tell your doctor if you have an enlarged prostate, problems passing urine, or a blockage in your bladder. SPIRIVA RESPIMAT may make these problems worse. If you have difficulty passing urine or painful urination, stop taking SPIRIVA RESPIMAT and call your doctor right away.

Tell your doctor if you have kidney problems.

Tell your doctor all the medicines you take, including eye drops. Ask your doctor if you are taking any anticholinergic medicines. Do not take SPIRIVA RESPIMAT with other anticholinergic medicines because taking them together can increase side effects.

Do not spray SPIRIVA RESPIMAT into your eyes.

Dizziness and blurred vision may occur with SPIRIVA RESPIMAT. If you experience these symptoms, use caution when engaging in activities such as driving a car or operating appliance or other machines.

The most common side effects reported with SPIRIVA RESPIMAT include sore throat, cough, dry mouth and sinus infection.

Click here for full SPIRIVA RESPIMAT Prescribing Information, including Instructions for Use

About Spiriva® HandiHaler® (tiotropium bromide inhalation powder)

Indication
SPIRIVA HandiHaler is a prescription medicine used once each day (a maintenance medicine) to control symptoms of chronic obstructive pulmonary disease (COPD) by relaxing your airways and keeping them open. COPD includes chronic bronchitis, emphysema, or both.

SPIRIVA HandiHaler also reduces the likelihood of flare-ups and worsening of COPD symptoms (COPD exacerbations).

Important Safety Information for Spiriva HandiHaler (tiotropium bromide inhalation powder)
Do not use SPIRIVA HandiHaler (tiotropium bromide inhalation powder) if you are allergic to tiotropium or ipratropium (e.g., Atrovent®) or any of the ingredients in SPIRIVA HandiHaler. If your breathing suddenly worsens, your face, throat, lips, or tongue swells, you get hives, itching or rash, stop taking SPIRIVA HandiHaler and seek immediate medical help.

SPIRIVA HandiHaler is not a rescue medicine and should not be used for treating sudden breathing problems.

Do not swallow SPIRIVA capsules. The contents of the capsule should only be inhaled through your mouth using the HandiHaler device.

If you have vision changes or eye pain or if you have difficulty passing urine or painful urination, stop taking SPIRIVA HandiHaler and call your doctor right away.

Tell your doctor if you have glaucoma, problems passing urine or an enlarged prostate, as these may worsen with SPIRIVA HandiHaler. Tell your doctor if you have kidney problems or are allergic to milk proteins. Ask your doctor if you are not sure. Also discuss with your doctor all the medicines you take, including eye drops.

The most common side effect with SPIRIVA HandiHaler is dry mouth. Others include constipation and trouble passing urine. For a complete list of reported side effects, ask your doctor or pharmacist.

Do not let the powder from the SPIRIVA capsule get into your eyes.

Dizziness and blurred vision may occur with SPIRIVA HandiHaler. Should you experience these symptoms, you should use caution when engaging in activities such as driving a car or operating appliances or other machines.

Read the Patient Information and the step-by-step Instructions for Use for SPIRIVA HandiHaler before you use your inhaler.

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, please visit www.spiriva.com, or call 1-800-542-6257 option #4.

Click here for full Spiriva HandiHaler Prescribing Information, Patient Information and Instructions for Use.

About COPD
Chronic obstructive pulmonary disease (COPD) is a term including chronic bronchitis and/or emphysema. This disease can make breathing harder because less air is able to flow in and out of the lungs. Chronic lower respiratory diseases, which include COPD, are the third leading cause of death in the United States, and approximately 15 million Americans have been told by a healthcare provider that they have COPD.

The most common symptom of COPD is shortness of breath, especially with physical activities. Coughing, with or without mucus production, is also a common symptom of COPD. These symptoms can be misunderstood as signs of aging. COPD is usually associated with progressive airway damage and loss that cause breathing to get more difficult.

Leading respiratory forward
Through research, Boehringer Ingelheim (BI) has developed drug therapies to help patients with lung diseases. 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 help patients with COPD, asthma, lung cancer, and idiopathic pulmonary fibrosis.

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 142 affiliates and more than 47,400 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.

Social responsibility is a central element of Boehringer Ingelheim's culture. 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 2013, Boehringer Ingelheim achieved net sales of about $18.7 billion (14.1 billion euro). R&D expenditure in the Prescription Medicines business corresponds to 19.5% of its net sales.

For more information please visit http://www.us.boehringer-ingelheim.com.