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Nebulized Formoterol Fumarate Has Comparable Pharmacokinetic and Pharmacodynamic Profile to Dry Powder Formulation
Date:5/20/2008

14: A Pharmacokinetic Study in COPD Patients Comparing

Formoterol Fumarate Delivered by Nebulization and DPI

The research presented at ATS 2008 was supported through grants provided by Dey, L.P., which developed and markets Perforomist(TM) Inhalation Solution. Dey, L.P. is a subsidiary of Mylan Inc. (NYSE: MYL).

About Perforomist(TM) Inhalation Solution

Indication

Perforomist(TM) Inhalation Solution is indicated for the long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema.

Important Safety Information

Perforomist(TM) Inhalation Solution belongs to a class of medications known as long-acting beta(2)-adrenergic agonists (LABAs). LABAs may increase the risk of asthma-related death. Data from a large placebo-controlled US study comparing the safety of another LABA (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a LABA), the active ingredient in Perforomist(TM) Inhalation Solution.

Perforomist(TM) Inhalation Solution should not be used in patients with acutely deteriorating COPD or to treat acute symptoms. Acute symptoms should be treated with fast-acting rescue inhalers. Perforomist(TM) Inhalation Solution should not be used with other medications containing LABAs. Do not use more than one nebule twice daily. Perforomist(TM) Inhalation Solution should be used with caution in patients with cardiovascular disorders. Perforomist(TM) Inhalation Solution is not a substitute for inhaled or oral corticos
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SOURCE Dey L.P.
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