Xopenex (levalbuterol) is a short-acting bronchodilator that relaxes airway muscles to increase air flow to the lungs. Xopenex was developed by Sunovion Pharmaceuticals and is approved by the U.S. Food and Drug Administration (FDA) to treat or prevent bronchospasms in adults and children 4 and older who have obstructive airway conditions, such as asthma and cystic fibrosis (CF).

How Xopenex works

CF is a heritable disorder characterized by the buildup of thick, sticky mucus in organs, interfering with their function. This mucus can obstruct airways and make it difficult for patients to breathe. 

Xopenex is a bronchodilator that usually is taken as an aerosol, using a metered dosage delivery device (also called an inhaler). Once inhaled, the active ingredient in Xopenex binds to beta-2-adrenergic receptors on the smooth muscles of the airways. This activates the receptors and leads to muscle relaxation, which widens the airways.

Xopenex in clinical trials

Xopenex has not been investigated in clinical trials specifically in people with CF. However, the safety and effectiveness of the treatment have been evaluated in a number of trials in other obstructive airway conditions, such as asthma, in both adults and children.

For example, two studies evaluated the safety and effectiveness of Xopenex in bronchospasm associated with asthma in adults and adolescents older than 12. A total of 748 adults and adolescents were included in the studies. The treatment group (403 patients) received Xopenex, while the control group (166 patients) received placebo. Serial forced expiratory volume in 1 second (FEV1, the total amount of air exhaled in one second in a forced exhalation), which is a measure of lung capacity, demonstrated improvement in patients treated with Xopenex compared to patients who received placebo.

Another study examined the safety and effectiveness of Xopenex in 150 children with asthma, ages 4 to 11. A total of 76 patients received Xopenex, while 35 patients received placebo. Serial FEV1 indicated that Xopenex produced a significantly greater improvement in FEV1 compared to placebo, consistent with the findings of trials in adults.

Other information

The most common side effects of Xopenex include accidental injury, bronchitis, dizziness, pain, sore throat, runny nose, vomiting, palpitations, chest pain, tremors, and nervousness.

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