SPIRIVA RESPIMAT Now Available in the U.S. for Maintenance Treatment of Asthma in Adults and Adolescents

SPIRIVA RESPIMAT is the first new class of inhaled medicine approved in over 10 years for the treatment of asthma

SPIRIVA RESPIMAT works differently than other medicines to help people with asthma breathe better

News provided by

Boehringer Ingelheim Pharmaceuticals, Inc.

Feb 03, 2016, 08:00 ET

RIDGEFIELD, Conn., Feb. 3, 2016 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced that SPIRIVA RESPIMAT is now available by prescription for the treatment of asthma in U.S. pharmacies. The U.S. Food and Drug Administration (FDA) approved a once-daily dose of SPIRIVA RESPIMAT 2.5 µg (delivered in 2 puffs of 1.25 µg each) for the long-term maintenance treatment of asthma in people ages 12 and older. SPIRIVA RESPIMAT is not a treatment for sudden asthma symptoms. In the treatment of asthma, the maximum benefits in lung function may take up to 4 to 8 weeks of dosing.

"Despite taking other daily maintenance treatments, many people with asthma continue to experience symptoms, including coughing, wheezing and shortness of breath," said Michael B. Foggs, MD, Chief of Allergy & Immunology, Advocate Medical Group, Advocate Health Care Chicago, IL. "For these patients, adding SPIRIVA RESPIMAT to maintenance controller therapy may help open airways to improve breathing and reduce the likelihood of asthma flare-ups or exacerbations*."

One survey found 55 percent of people with asthma taking at least one treatment still experienced symptoms, which can have a negative impact on their ability to perform daily activities.

Unlike other asthma daily maintenance treatments, SPIRIVA RESPIMAT is from a new class of medications in asthma known as long-acting muscarinic antagonists (LAMAs), the first new class of inhaled medicine approved in over 10 years for asthma. As a LAMA, it is steroid-free and works differently than a long-acting beta₂ agonist (LABA).

Unlike many newly introduced prescription medicines, formulary access for SPIRIVA RESPIMAT in asthma (https://www.spiriva.com/asthma) is already favorable and widely covered by most major Commercial and Medicare insurance plans – with similar formulary access to SPIRIVA RESPIMAT in chronic obstructive pulmonary disease (COPD).

In addition, Boehringer Ingelheim will offer a savings card that will allow most eligible people to obtain SPIRIVA RESPIMAT for the treatment of asthma at no cost for 12 consecutive months, depending on their insurance provider. This savings card is available on www.SpirivaSavings.com and in the SPIRIVA RESPIMAT patient brochure. The savings card can be activated at most pharmacies.

SPIRIVA RESPIMAT is approved at two different doses, one for asthma and one for COPD. For asthma, it is approved as a once-daily dose of 2.5 µg (delivered in 2 puffs of 1.25 µg each). SPIRIVA RESPIMAT is also approved as a once-daily dose of 5 µg (delivered in 2 puffs of 2.5 µg each) for the maintenance treatment of COPD. Both doses for SPIRIVA RESPIMAT should be taken as 2 puffs once daily.

"As an industry leader in respiratory, Boehringer Ingelheim is committed to addressing unmet needs and to improving patient care for those with serious respiratory diseases, such as asthma," said Clare Burrows, vice president, Respiratory Marketing, Boehringer Ingelheim Pharmaceuticals, Inc. "The approval of SPIRIVA RESPIMAT marks our entrance into the asthma space and we are proud to offer a new approach for healthcare providers and patients to consider for the treatment of asthma."

The FDA approved SPIRIVA RESPIMAT for the treatment of asthma based on efficacy and safety data from a comprehensive clinical trial program, including 12 trials of approximately 5,000 adults and adolescents with mild, moderate and severe symptomatic asthma on at least an inhaled corticosteroid (ICS) or ICS/LABA.

For additional information, please visit https://www.spiriva.com/asthma.

About the RESPIMAT Inhaler
The RESPIMAT is the platform inhaler for the Boehringer Ingelheim respiratory therapies. RESPIMAT is the only inhaler that actively delivers a slow-moving mist that helps patients inhale the medication.

The RESPIMAT inhaler delivers medication independent of the degree or strength of inspiratory effort. As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as coordination between actuation of the inhaler and inspiration through the delivery system. The duration of inhalation should be at least as long as the spray duration (1.5 seconds).

About SPIRIVA RESPIMAT in COPD
This FDA approval for asthma is the second indication for SPIRIVA RESPIMAT, which is already approved for the long-term, once-daily maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema and to reduce exacerbations in COPD patients. SPIRIVA RESPIMAT is not indicated for the relief of acute bronchospasm.

Click here for full Prescribing Information, including Instructions for Use.

INDICATIONS

SPIRIVA RESPIMAT, 2.5 µg/actuation, is a long-term, once-daily, prescription maintenance medicine used to control symptoms of chronic obstructive pulmonary disease (COPD) by relaxing your airways and keeping them open. COPD includes chronic bronchitis and emphysema. SPIRIVA RESPIMAT also reduces the likelihood of COPD flare-ups (COPD exacerbations).

SPIRIVA RESPIMAT, 1.25 µg/actuation, is a long-term, once-daily, prescription maintenance treatment of asthma for people 12 years and older.

SPIRIVA RESPIMAT is not a treatment for sudden symptoms of asthma or COPD.

IMPORTANT SAFETY INFORMATION

Do not use SPIRIVA RESPIMAT if you are allergic to tiotropium, ipratropium, atropine or similar drugs, or any ingredient in these medicines.

SPIRIVA RESPIMAT is not a rescue medicine and should not be used for treating sudden breathing problems. Your doctor may give you other medicine to use for sudden breathing problems.

SPIRIVA RESPIMAT can cause allergic reactions. Symptoms can include raised red patches on your skin (hives), itching, rash and/or swelling of the lips, tongue or throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking the medicine and seek emergency medical care.

SPIRIVA RESPIMAT can cause your breathing to suddenly get worse (bronchospasm). If this happens, use your rescue inhaler, stop taking SPIRIVA RESPIMAT, and call your doctor right away or seek emergency medical care.

SPIRIVA RESPIMAT can increase the pressure in your eyes (acute narrow-angle glaucoma), which can cause the following symptoms: eye pain, blurred vision, seeing halos or colored images, along with red eyes. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

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 appliances or other machines.

SPIRIVA RESPIMAT can cause new or worsened urinary retention. Symptoms of blockage in your bladder and/or enlarged prostate may include difficulty passing urine and/or painful urination. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

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

The most common side effects with SPIRIVA RESPIMAT in adult patients with asthma were sore throat, sinus infection, bronchitis, and headache.

Do not spray SPIRIVA RESPIMAT into your eyes, as this may cause blurring of vision and pupil dilation.

Tell your doctor about all your medical conditions including kidney problems, glaucoma, enlarged prostate, problems passing urine, or blockage in your bladder.

Tell your doctor all the medicines you take, including eye drops. Ask your doctor if you are taking any anticholinergic medicines because taking them together with SPIRIVA RESPIMAT can increase side effects.

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.

Please see full Prescribing Information for SPIRIVA RESPIMAT, including Instructions for Use.

About Asthma
More than 22 million people in the U.S. have asthma. Asthma is a chronic disease and in the U.S., many patients taking currently available asthma treatments continue to experience symptoms. In a web-based survey of 1,812 asthma patients, 55 percent of patients taking asthma treatment still remained uncontrolled.

When a person with asthma comes into contact with an asthma trigger (e.g., infections, pollen, smoke), their airways can become inflamed, swollen and constricted and excess mucus is produced. These reactions can cause the airways to become narrower and irritated, making it difficult to breathe. People suffering from asthma experience recurrent episodes of wheezing, breathlessness, chest tightness and coughing. Asthma attacks occur when symptoms become more intense or frequent.

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.

Boehringer Ingelheim is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 146 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and families. Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.

In 2014, Boehringer Ingelheim achieved net sales of about $16.96 billion dollars (13.3 billion euros). R&D expenditure corresponds to 19.9 percent of its net sales.

For more information please visit http://us.boehringer-ingelheim.com/, or follow us on Twitter @BoehringerUS.

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*An asthma exacerbation is defined as a progressive increase in asthma symptoms (shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms) or a decrease in a patient's best morning peak expiratory flow (PEF) that requires treatment with systemic steroids for at least three days.

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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.