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Published on 5/24/2006 in the Prospect News Biotech Daily.

Sepracor reports two studies show arformoterol helps in chronic obstructive pulmonary disease

New York, May 24 - Sepracor Inc. presented results from two studies showing benefits of arformoterol tartrate inhalation solution for long-term maintenance treatment of chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

Both studies were presented in posters at the International Conference of the American Thoracic Society in San Diego. The company's New Drug Application for arformoterol tartrate inhalation solution is currently being reviewed by the Food and Drug Administration.

In a phase 3 study of 717 patients, arformoterol showed airway function improvement in patients with chronic obstructive pulmonary disease.

Patients in the multicenter, double-blind, double-dummy, randomized trial were treated with either arformoterol 50 micrograms once daily, arformoterol 25 micrograms twice daily, arformoterol 15 micrograms twice daily, salmeterol metered-dose inhaler (Serevent) 42 micrograms twice daily, or a placebo.

Both an albuterol metered-dose inhaler as rescue therapy and an ipratropium bromide metered-dose inhaler as supplemental medication for chronic obstructive pulmonary disease were provided to all patients to be used on an as-needed basis.

Patients treated with arformoterol by nebulizer demonstrated significant and sustained improvement in airway function over 12 weeks of treatment versus patients administered placebo.

The second study involved 62 patients with chronic obstructive pulmonary disease. It evaluated bronchodilation produced by arformoterol 9.6 micrograms once daily, 24 micrograms twice daily, 48 micrograms once daily and 96 micrograms once daily and salmeterol 42 micrograms twice daily, versus a placebo.

Both an albuterol metered-dose inhaler as rescue therapy and an ipratropium bromide metered-dose inhaler as supplemental medication for chronic obstructive pulmonary disease were provided to be used as needed.

Patients treated with arformoterol showed significant improvement in bronchodilation.

Sepracor is a Marlborough, Mass., pharmaceutical company.


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