FDA approves Atrovent(REG) HFA for treatment of COPD bronchospasms

Main Category: COPD
Article Date: 24 Nov 2004 - 12:00 PDT

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Boehringer Ingelheim Pharmaceuticals, Inc announced today that the US Food and Drug Administration has approved new Atrovent(REG) 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 a new drug formulation that was developed to provide COPD patients a therapeutic benefit comparable to Atrovent (ipratropium bromide) (CFC) Inhalation Aerosol, a leading treatment for COPD.

New Atrovent HFA is formulated with a non-chlorofluorocarbon (CFC) propellant called HFA (hydrofluoroalkane) that was developed in response to the Montreal Protocol on Substances that Deplete the Ozone Layer. The Montreal Protocol, a global agreement to protect the ozone layer, requires the removal of ozone depleting substances including CFC propellants. The agreement recognizes the special needs of the world's respiratory patients who require inhalation therapy, and the essential role of the pressurized metered-dose inhaler, and therefore grants these products an exemption until they can be replaced by non-CFC alternatives. Boehringer Ingelheim supports the Montreal Protocol and will replace the company's CFC inhalers once the replacement products are available.

"Boehringer Ingelheim is proud to offer patients a comparably safe and effective replacement product for Atrovent CFC," said Steven Kesten, M.D, Therapeutic Director in Clinical & Scientific Affairs for Boehringer Ingelheim Pharmaceuticals, Inc. "This approval is in keeping with our commitment to the research and development of replacements to our CFC-based inhalers."

Worldwide, Boehringer has more than 200 scientists working in 35 different laboratories and has invested more than $500 million dollars in the reformulation of its metered-dose inhaler products, including ATROVENT and COMBIVENT (ipratropium bromide and albuterol sulfate) Inhalation Aerosol.

In 2005, Boehringer Ingelheim will educate patients about new Atrovent HFA through doctors and pharmacies, while it begins phasing out the Atrovent (CFC) metered-dose inhalers.

Clinical Trials

A 12-week, double-blind, placebo and active-controlled trial established the comparable safety and efficacy of Atrovent HFA to Atrovent (CFC). The data were confirmed in a one-year randomized, open-label, parallel-group multi-center trial comparing Atrovent HFA to Atrovent (CFC). Both products were shown to be safe and effective with no statistically significant differences between them. Both products significantly improved lung function in patients with COPD. The most common drug-related adverse events in clinical trials with ATROVENT HFA were dry mouth (1.6%) and taste perversion (bitter taste) (0.9%).

Atrovent HFA is contraindicated in patients with a history of hypersensitivity to ipratropium bromide or other Atrovent HFA components and should also not be taken by patients hypersensitive to atropine or its derivatives.

Atrovent HFA is not indicated for the initial treatment of acute episodes of bronchospasm where rapid response is required. Immediate hypersensitivity reactions may occur after administration of ipratropium bromide, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis and oropharyngeal edema.

COPD

COPD, the fourth leading cause of death in the United States, is a respiratory disease primarily caused by smoking that is more commonly known as chronic bronchitis or emphysema. There are an estimated 24 million Americans who suffer from COPD, however only 10 million have been diagnosed with the illness and approximately six million currently are receiving therapy. Most people with COPD are at least 40 years old when they begin to notice symptoms which may include shortness of breath after exertion, chronic cough, excess mucus production and wheezing.

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 152 affiliates in 45 countries and more than 34,000 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 2003, Boehringer Ingelheim posted net sales of US $8.37 billion (7.4 billion euro) while spending more than one fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

Notes to the editor

The Montreal Protocol and several supplementary legally binding international agreements lay down the gradual elimination of all production and use of ozone depleting substances, particularly chlorofluorocarbons (CFCs) which have been widely used as aerosol propellants. Of particular relevance to Boehringer Ingelheim is the switch from CFC-driven Metered Dose Inhalers to those propelled by the more environmentally-friendly hydrofluoroalkanes (HFAs). Boehringer Ingelheim has already launched HFA-products for their established bronchodilators in many countries, and has also given a lot of attention to the development of an alternative inhaler device that is propellant-free.

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