US FDA has approved Sepracor's New Drug Application (NDA) for Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol, a hydrofluoroalkane (HFA) metered- dose inhaler (MDI) for the treatment or prevention of bronchospasm in adults, adolescents and children 4 years of age and older with reversible obstructive airway disease. Reversible obstructive airway disease includes respiratory disorders such as asthma and chronic obstructive pulmonary disease (COPD).

Mark H.N. Corrigan, executive vice president, Research and Development at Sepracor. "We expect that the Xopenex HFA MDI will make Xopenex available to the large number of adult and children asthmatics who prefer the convenience of an MDI as part of their therapy. This product will also allow those patients who are currently benefiting from therapy with Xopenex brand levalbuterol HCl Inhalation Solution administered by nebulization, to continue to use Xopenex when therapy with a hand-held device is appropriate."

The MDI development programme included approximately 1,870 paediatric and adult subjects and 54 studies (preclinical and clinical). In 2003, Sepracor completed its Phase III studies of Xopenex HFA. In each of the three, large- scale, pivotal Phase III trials that Sepracor conducted, 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, the release says.

Sepracor's Xopenex MDI utilizes state-of-the-art HFA technology and does not contain a chlorofluorocarbon (CFC) propellant. MDIs are portable, hand- held devices consisting of a pressurized canister containing medication and a mouthpiece through which the medicine is inhaled. Each canister provides 200 actuations (or inhalations). Sepracor and 3M Drug Delivery Systems Division are collaborating under an agreement that includes scale-up, manufacturing and supply of the Xopenex HFA. 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 COPD.

Currently, the US short-acting bronchodilator MDI market potential at branded prices, assuming parity pricing to branded Proventil HFA, is approximately $1.8 billion.