Xopenex (Levalbuterol) Safe, Effective First Line Therapy For Adult Chronic Obstructive Pulmonary Disease, Asthma

SOUTH BOSTON, VA -- January 15, 2003 -- Data from a study published in the current issue of Chest, The Cardiopulmonary and Critical Care Journal, suggest nebulized Xopenex (levalbuterol) as an effective first-line therapy for hospitalized adults with chronic obstructive pulmonary disease (COPD) or asthma.

The study was conducted at Halifax Regional Hospital in South Boston, VA. Data were developed through a retrospective chart review of hospitalized dult patients in a "real world" community-based setting, according to lead author Terrance Truitt, MD, FCCP. The purpose of the investigation was to evaluate the impact of Xopenex on clinical effectiveness, patient outcomes and direct medical costs, according to Dr. Truitt.

The study is the first published to suggest Xopenex as a viable first-line therapy for hospitalized adult COPD or asthma patients. COPD, including chronic bronchitis and emphysema, is characterized by breathing difficulty due to partial blockage of the bronchial tubes. According to the American Lung Association, it affects 16 million people in the United States and is the fourth most common cause of death. Asthma is a chronic lung disease caused by inflammation of the lower airways resulting in episodes of airflow obstruction. According to the American Lung Association, approximately 26 million Americans have been diagnosed with asthma in their lifetime. It is the most common childhood illness and affects approximately 8.6 million children in the U.S. under the age of 18.

"Xopenex in the hospital setting is a safe, and effective alternative to racemic albuterol in treating the bronchial smooth muscle spasm associated with diseases such as COPD and asthma," Truitt said. Patients receiving Xopenex also required significantly less nebulizer therapy and less adjuvant respiratory therapy, according to the article in the January issue of Chest Journal.

The study, the results of which are supported by Sepracor, Inc., the maker of Xopenex, compared the treatment of 231 patients with similar background and disease conditions over two separate six-month periods. The first group had been treated with the previous standard treatment, the second group with Xopenex.

The study showed that patients demonstrated significant symptom improvement and a change in the frequency of nebulizer treatments -- in intervals of 6 to 8 hours. This change was achieved with a 1.25 mg dose of Xopenex. In addition the Xopenex group needed only 2.0 ± 2.6 days of ipratropium bromide treatments. Other institutions may have varying results.

Xopenex
XOPENEX brand levalbuterol HCl inhalation solution is indicated for the treatment or prevention of bronchospasm in patients 6 years and older with reversible obstructive airway disease, such as asthma. XOPENEX is marketed for use in a nebulizer at dosage strengths of 0.31 mg and 0.63 mg for pediatric patients and is marketed at dosage strengths of 0.63 mg and 1.25 mg for patients 12 years of age and older.

Halifax Regional Hospital
Halifax Regional Hospital, an affiliate of Halifax Regional Health System, is a not-for-profit, community-owned facility located in South Boston, Virginia. The 192-bed hospital is JCAHO accredited and serves approximately 80,000 residents in Southside Virginia.