EndocrinologyPerforomist Inhalation Solution Data Presented At American Thoracic Society Conference
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 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, pCurrent 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 http://www.perforomist.com.
Julie Piszczor
Powell Tate