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.
The complete study results were presented at the 2008 CHEST meeting, and recently published in Current Medical Research and Opinion in 2009.
The research presented at ATS 2009 was sponsored by Dey, L.P., which developed and markets Perforomist Inhalation Solution.
About COPD
COPD is a preventable and treatable disease with some significant extrapulmonary effects that may contribute to the severity in individual patients. Its pulmonary component is characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lung to noxious particles or gases.
COPD is the fourth leading cause of death in America, behind heart disease, cancer and stroke. 12 million Americans have been diagnosed with COPD, and at least another 12 million have symptoms but have not been diagnosed. COPD is not well understood or recognized ? most Americans have not heard of it, not even those who may be living with the condition. The most common cause of COPD is cigarette smoking, which is responsible for an estimated 80 to 90 percent of COPD cases. For patients who smoke, quitting smoking is the single most important step a patient can take to treat or slow down COPD. Estimates of the total incidence of COPD in America range from 24 to 30 million.
About Nebulization
Of the three types of devices used to deliver bronchodilators ? nebulizers, metered-dose inhalers, and dry powder inhalers ? nebulizers convert medication into a fine liquid mist that the patient inhales through a mouthpiece or facemask. The patient breathes naturally, inhaling the medicine until the complete dosage has been delivered. Nebulization is a very gentle, but also very thorough, method of delivering medicine directly into the lungs.
With Perforomist Inhalation Solution, nebulization may become a more widely used treatment option for many COPD patients at earlier treatment stages who could benefit from twice-daily maintenance dosing of a nebulized long-acting beta2-adrenergic agonists (LABAs) such as Perforomist Inhalation Solution. For example, this COPD treatment may be a valuable clinical option for many patients whose symptoms are not adequately controlled with their current therapy. COPD patients should consider asking their doctor whether nebulized treatment may be right for them.
About Perforomist® Inhalation Solution
Perforomist 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® (formoterol fumarate) Inhalation Solution belongs to a class of medications known as long-acting beta2-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 Inhalation Solution.
Perforomist Inhalation Solution should not be initiated in patients with acutely deteriorating COPD, which may be a life threatening condition, or to treat acute symptoms. Acute symptoms should be treated with fast-acting rescue inhalers. Perforomist Inhalation Solution is not indicated to treat asthma. The safety and efficacy of Perforomist Inhalation Solution in asthma has not been established. Perforomist Inhalation Solution should not be used with other medications containing LABAs. Do not use more than one nebule twice daily. Perforomist Inhalation Solution should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias and hypertension.
In COPD clinical trials, the most common adverse events reported with Perforomist Inhalation Solution (>2% and more common than placebo) were diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and insomnia.
Please see full Prescribing Information, including Boxed Warning, at www.perforomist.com or call 800-755-5560 and ask for Customer Service.
About Dey, L.P.
Dey, L.P., a subsidiary of Mylan Inc. (NYSE: MYL), is a specialty pharmaceutical company focused on the development, manufacturing and marketing of prescription drug products for the treatment of respiratory diseases, respiratory-related allergies, and emergency care medicine. As the U.S. leader in sales of nebulized respiratory medication, Dey, L.P. puts patients first through its development of innovative and affordable therapies. The Web sites for Dey, L.P. include www.dey.com, www.curosurfusa.com, www.epipen.com and www.perforomist.com.
About Mylan
Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generics and specialty pharmaceutical companies in the world. The company maintains one of the industry’s broadest ? and highest quality ? product portfolios, supported by a robust product pipeline; owns a controlling interest in the world’s third largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies. For more information about Mylan, please visit www.mylan.com.
