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Perforomist Inhalation Solution data to be presented today at American Thoracic Society conference
Date:5/19/2009

San Diego, Calif., May 19, 2009 Data from two presentations highlighting the use of Perforomist (formoterol fumarate) Inhalation Solution in moderate to severe chronic obstructive pulmonary disease (COPD) patients were featured today at the International Conference of the American Thoracic Society in San Diego. In one analysis, use of Perforomist Inhalation Solution, when added to maintenance tiotropium, resulted in improved pulmonary function, dyspnea (shortness of breath) and rescue medication use versus treatment with tiotropium alone. In a second study, patient satisfaction increased in those treated with Perforomist Inhalation Solution twice daily compared with ipratropium/albuterol metered-dose inhaler (MDI) four times daily.

Perforomist Inhalation Solution was approved in 2007 by the U.S. Food and Drug Administration (FDA) for long-term, twice-daily maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema. It is the only FDA-approved nebulized formoterol fumarate.

"These results are significant because they validate the benefits and satisfaction when using Perforomist," said Carolyn Myers, Ph.D., President of Mylan's specialty division, which includes Dey, L.P. "We continue our dedication to further research surrounding illnesses such as COPD, and are pleased that patients can benefit from our treatments."

Studies Find Improvements in Pulmonary Function, Dyspnea, and Rescue Medication Use

A pooled analysis of two similar studies evaluated the efficacy and safety of adding Perforomist Inhalation Solution to maintenance tiotropium in patients with moderate to severe COPD versus treatment with tiotropium alone.

This data analysis assessed a combined total of 285 subjects with moderate to very severe COPD. When combining Perforomist Inhalation Solution with maintenance tiotropium in such patients, significant improvements in pulmonary function, dyspnea and rescue medication use were seen over tiotropium treatment alone, without any additional safety or tolerability issues.

Efficacy was measured by serial spirometry, transitional dyspnea index (TDI), rescue albuterol use and the St. George's Respiratory Questionnaire (SGRQ).

The primary efficacy endpoint was standardized absolute FEV1 AUC0-3. At Week 6 the primary efficacy endpoint was significantly improved by 192 mL compared with placebo/tiotropium (1.54 versus 1.37 L, p<0.0001). Following treatment, the mean TDI score showed a significant and clinically meaningful improvement in dyspnea in the Perforomist Inhalation Solution/tiotropium group compared with the placebo/tiotropium group, with mean TDI scores of 1.97 and 0.67, respectively (p=0.0001).

When Perforomist Inhalation Solution was added to tiotropium there was a significant decrease in the need for rescue albuterol use throughout the double-blind period compared with placebo/tiotropium (p<0.0001). SGRQ scores were similar both between treatments and to baseline, except the symptom domain score, which fell in the Perforomist Inhalation Solution/tiotropium group (-5.8) compared with placebo/tiotropium group (-1.0).

Overall, 31 percent of Perforomist Inhalation Solution/tiotropium-treated subjects experienced adverse events versus 46 percent of the placebo/tiotropium-treated subjects. COPD exacerbations were the most common adverse events, and occurred in over twice as many placebo/tiotropium-treated subjects as Perforomist Inhalation Solution/tiotropium-treated subjects. The most frequent adverse events following COPD exacerbations were acute bronchitis and upper respiratory tract infections.

"COPD patients in this analysis saw improvement in several areas when adding Perforomist Inhalation Solution to their tiotropium treatment," said Davida J. White Pettaway, M.D., Senior Manager, Medical and Scientific Affairs, Dey, L.P. "Having replicate data from two well-controlled, double-blind studies will provide physicians with valuable information as they consider treatment options for patients with moderate to severe COPD."

Results Suggest Increased Treatment Satisfaction with Twice Daily Perforomist Inhalation Solution Compared with Ipratropium/Albuterol MDI Four Times Daily

In a separate poster presentation, results were presented from a post-hoc analysis conducted to assess the effects of age, gender and COPD severity on patient responses to Perforomist Inhalation Solution and ipratropium/albuterol MDI.

"Nebulized Formoterol Improved Efficacy and Increased Patient Satisfaction Compared with Ipratropium/Albuterol MDI," led by E. Rand Sutherland, M.D., M.P.H., National Jewish Health, Denver, Colo., was a multicenter, randomized, open-label, crossover study of 109 patients with moderate to severe COPD. Perforomist Inhalation Solution was shown to provide superior morning bronchodilation and increased patient satisfaction versus ipratropium/albuterol MDI in older, male and more severe patients with COPD.

Efficacy was assessed by spirometry, TDI and a treatment preference/satisfaction survey. Subgroups with a significant difference in pre-treatment FEV1 on Day 14 favoring Perforomist Inhalation Solution were older, (≥65 years), severe to very severe COPD (<50 percent predicted) or moderate COPD, and males (p<0.05). Other results demonstrated that severe/very severe subjects preferred Perforomist Inhalation Solution (p<0.05). Significantly more older, male and severe/very severe subjects were satisfied with their overall response to Perforomist Inhalation Solution and more males and severe/very severe subjects perceived increased medication delivery to the lung and overall control of lung disease following treatment with Perforomist Inhalation Solution (p<0.05). Improvements in dyspnea were clinically meaningful, but not significantly different between treatments in any subgroup.


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Contact: Julie Piszczor
jpiszczor@powelltate.com
202-585-2106
Powell Tate
Source:Eurekalert

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