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Xopenex Metered-Dose Inhaler Well Tolerated in Phase III Trials

MARLBOROUGH, Mass., Dec. 2 /PRNewswire/ -- Sepracor Inc. today announced results from its Phase III clinical program of the XOPENEX® (levalbuterol tartrate) hydrofluoroalkane (HFA) metered-dose inhaler (MDI).

In each of the three, large-scale pivotal Phase III trials conducted by Sepracor, the XOPENEX HFA MDI was well tolerated and met the targeted efficacy endpoints in both adults and children with asthma. In the primary airway function measure, FEV1 (a test of lung function that measures the amount of air forcefully exhaled in one second), the XOPENEX HFA MDI produced statistically and clinically significant improvements relative to placebo (p

Sepracor's MDI development program includes over 1,800 pediatric and adult subjects in 12 clinical studies. All clinical studies that Sepracor plans to include in the XOPENEX HFA MDI New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) have been completed. Sepracor is preparing its NDA for the XOPENEX MDI and has targeted submission to the FDA for the end of the first quarter of 2004. The U.S. short-acting bronchodilator MDI market potential at branded prices is approximately $1.4 billion.(1)

"If approved, the XOPENEX MDI will expand our franchise by making XOPENEX available to the large number of adult and teenage asthmatics who prefer the convenience of an MDI as part of their therapy. The MDI delivery system will also allow those pediatric patients who are currently benefiting from nebulizer therapy with XOPENEX inhalation solution to continue to use XOPENEX when therapy with a hand-held device is appropriate," said Mark H.N. Corrigan, M.D., Executive Vice President, Research and Development at Sepracor.

Sepracor and 3M Drug Delivery Systems Division are collaborating under an agreement that includes scale-up and manufacturing for the XOPENEX HFA MDI. The collaboration combines Sepracor's short-acting beta-agonist, XOPENEX, and 3M's expertise in manufacturing MDIs, the device most commonly used by patients for the treatment of asthma and chronic obstructive pulmonary disease (COPD).

Sepracor currently markets XOPENEX brand levalbuterol HCl inhalation solution through Sepracor's 450-person sales force. XOPENEX inhalation solution is a short-acting bronchodilator indicated for the treatment or prevention of bronchospasm in patients 6 years of age and older with reversible obstructive airway disease, such as asthma. XOPENEX is available for use in a nebulizer at 0.31 mg and 0.63 mg dosage strengths for treatment of children 6 to 11 years old, and in 0.63 mg and 1.25 mg dosage strengths for patients 12 years of age and older. XOPENEX inhalation solution revenues for the nine months ended September 30, 2003 were approximately $186.6 million, an increase of 50 percent from the nine months ended September 30, 2002. XOPENEX inhalation solution market share of new prescriptions in the unit-dose vial segment was approximately 26 percent as of the end of the third quarter 2003.

Asthma is a chronic lung disorder characterized by reversible airway obstruction and the pathologic finding of airway inflammation. 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. Short-acting beta-agonists are the most-prescribed asthma therapy among primary care physicians and pediatricians in the U.S., according to IMS Health information.

Source: Sepracor Inc.

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