MIDLOTHIAN, Va., Oct. 9 /PRNewswire/ -- PARI Respiratory Equipment's breath-enhanced nebulizer, the PARI LC PLUS, and PRONEB Ultra compressor deliver Dey, L.P.'s new COPD medication, Perforomist Inhalation Solution, that launched nationwide yesterday. Dey, L.P. is a subsidiary of Mylan Inc. (NYSE: MYL).
Perforomist (formoterol fumarate) Inhalation Solution is indicated for long-term, twice-daily maintenance treatment of bronchoconstriction for emphysema and chronic bronchitis, also known as Chronic Obstructive Pulmonary Disease (COPD). Perforomist Inhalation Solution will be available through retail pharmacies, hospitals, long-term care facilities, and home healthcare companies.
"We are extremely pleased that our PARI LC PLUS nebulizer and PRONEB Ultra compressor were chosen exclusively for the clinical trials for Perforomist Inhalation Solution and are on the package insert. PARI's nebulizers and compressors are the top performers in the industry, which makes them a perfect fit for many of DEY's products -- including DuoNeb, AccuNEB, and now Perforomist," said Geoff A. Hunziker, President of PARI in the United States.
Formoterol fumarate is a rapid, long-acting beta(2)-agonist (LABA) that has been previously available in the U.S. as a dry powder formulation and has twenty years of worldwide use.
The safety and efficacy of Perforomist Inhalation Solution have been established in clinical trials when administered using the PARI LC PLUS nebulizer (with a facemask or mouthpiece) and the PARI PRONEB Ultra compressor. The safety and efficacy of Perforomist Inhalation Solution delivered from other compressor-based nebulizer combinations and non-compressor based nebulizer systems have not been established.
The PARI LC PLUS and the PRONEB Ultra are the most frequently used compressor-based nebulizer system for new nebulized medications in clinical development.
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 http://www.perforomist.com
COPD refers to a number of chronic lung disorders in which the airways to the lungs become narrowed and breathing becomes progressively 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 are undiagnosed.
Advancements Offered by Nebulization
Perforomist Inhalation Solution is a long-acting bronchodilator that is taken by nebulizer. 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 liquid medication is converted into a fine mist that patients inhale through a mouthpiece or face-mask while breathing naturally. Since nebulization is an easy, effective, and thorough method of delivering medication directly into the lungs, many COPD patients ask for it, particularly as their symptoms worsen.
Dey, L.P. 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. Dey, L.P. is a subsidiary of Mylan Inc. (NYSE: MYL).
About PARI Respiratory Equipment, Inc.
PARI is a leading worldwide developer and manufacturer of fast and efficient aerosol delivery systems for patients with asthma, chronic lung disease, and cystic fibrosis. PARI's worldwide vision is to improve the lives of those affected by respiratory diseases and those who care for them. Maker of the world's leading breath-enhanced reusable nebulizer, the PARI LC PLUS, and the new PARI LC Sprint nebulizer line, PARI also manufactures the award-winning PARI TREK S compact compressor, the innovative aerosol mask Bubbles the Fish II, and powerful PARI PRONEB Ultra II. PARI's North American headquarters is in Midlothian, VA with worldwide headquarters in Starnberg, Germany. Online at http://www.Pari.com
Additional information is available by contacting Ayars & Associates at 805-566-2986 or Ashley Weigand at 804-253-7274 x711.
|SOURCE PARI Respiratory Equipment, Inc.|
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