Napa, CA (May 20, 2008) – Data presented today at the International Conference of the American Thoracic Society (ATS) demonstrate that concomitant therapy with Perforomist™ Inhalation Solution (formoterol fumarate inhalation solution; FFIS), delivered by nebulization, and Spiriva® (tiotropium; TIO) is significantly more effective than treatment with tiotropium alone.
Perforomist™ Inhalation Solution was approved in 2007 by the FDA for long-term, twice-daily maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is the only FDA-approved nebulized formoterol fumarate.
Donald P. Tashkin, MD, FACP, FCCP, Professor of Medicine, David Geffen School of Medicine at the University of California at Los Angeles and lead clinical investigator, presented the results from “Addition of Nebulized Formoterol Fumarate to Tiotropium Treatment Relieves Dyspnea and Symptoms in COPD Patients” in a poster session today.
“In this study there was a significant improvement in patients treated concomitantly with Perforomist™ nebulized formoterol fumarate and tiotropium over tiotropium alone,” said Dr. Tashkin. “These data provide physicians with a new and valuable treatment option for COPD patients with moderate to severe manifestations of the disease.”
This randomized, placebo-controlled double-blind trial was conducted in 130 patients with moderate to severe COPD to evaluate the efficacy and safety of Perforomist™, nebulized FFIS, when added to Spiriva maintenance treatment. Patient-centered outcomes were measured by the baseline/transitional dyspnea index, daily recording of COPD symptoms, rescue albuterol use and St. George’s Respiratory Questionnaire (SGRQ).
In this trial there was a statistical significance between the mean transitional dyspnea index scores in the Perforomist™/TIO and TIO/placebo groups (2.30 and 0.16, respectively; p=0.0002). Shortness of breath, chest tightness, nighttime awakenings, and total symptom scores all improved significantly with the Perforomist™/TIO treatment compared with TIO/placebo (p<0.05). Cough scores did not differ between groups. Albuterol use declined in the Perforomist™/TIO group from 2.4 to1.3 puffs/day and increased in the TIO/placebo group from 2.8 to 3.4 puffs/day over six weeks; another statistically significant difference (p< 0.0001). SGRQ total scores did not change markedly from baseline or differ between groups except for the symptom domain score, which was superior in the Perforomist™/TIO group compared to TIO/placebo (-6.3, p<0.04).
“DEY is very pleased with the results of this study and the benefit that patients are seeing with Perforomist™ Inhalation Solution,” said Carolyn Myers, Ph.D., President of Dey, L.P. “We wish to thank Dr. Tashkin and the other members of the research team for their careful investigation into the clinical benefits of concomitant therapy of Perforomist and tiotropium. At DEY, we are committed to developing effective new treatments for serious and complex diseases, and with Perforomist are proud to provide physicians and patients a twice-daily COPD maintenance medication that offers the flexibility of dosing via nebulization.”
For those attending ATS 2008, the presentation is available as follows:
Poster viewing: Session ID C42 COPD Pharmacotherapy I: Effects of Bronchodilators Tuesday, May 20, 2008, 10:45 a.m. – 12:30 p.m. EDT Metro Toronto Convention Center; Area F: Halls A-B North Building, Level 300
Poster # F4: Addition of Nebulized Formoterol Fumarate to Tiotropium Treatment Relieves Dyspnea and Symptoms in COPD Patients
The research presented at ATS 2008 was supported through grants provided by Dey, L.P., which developed and markets Perforomist™ Inhalation Solution. Dey, L.P. is a subsidiary of Mylan Inc. (NYSE: MYL).
About Perforomist™ Inhalation Solution
Indication
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™ 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 used in patients with acutely deteriorating COPD or to treat acute symptoms. Acute symptoms should be treated with fast-acting rescue inhalers. 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. Perforomist™ Inhalation Solution is not a substitute for inhaled or oral corticosteroids. The safety and efficacy of Perforomist™ Inhalation Solution in asthma has not been established.
In COPD clinical trials, the most common adverse events reported with Perforomist™ Inhalation Solution 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 COPD
COPD refers to a number of chronic lung disorders in which the airways to the lungs become narrowed and breathing becomes increasingly difficult. The most common forms of COPD are chronic bronchitis and emphysema and many patients suffer from a combination of the two diseases.
COPD is the fourth leading cause of death in America, behind heart disease, cancer and stroke. Twelve 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. 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 require no special technique or coordination, as the medication is converted into a fine mist that the patient inhales through a mouthpiece or face-mask while breathing naturally. Nebulization is an easy and effective method of delivering medicine directly into the lungs for patients, particularly as their symptoms worsen.
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 LABA such as Perforomist™ Inhalation Solution. For example, this new 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 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.accuneb.com, www.curosurfusa.com, www.cyanokit.com, www.duoneb.com, www.epipen.com and www.perforomist.com.
Perforomist™ is a trademark of Dey, L.P.
Spiriva® is a registered trademark of Boehringer Ingelheim Pharmaceuticals, Inc.