Three Clinical Trials For Perforomist Inhalation Solution Are Promising

Armen Hareyan's picture
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Dey L.P. will present data from two safety studies that were included as part of the New Drug Application (NDA) filing to FDA for Perforomist Inhalation Solution. The third presents results from a Phase IIIb study of the concomitant use of Perforomist Inhalation Solution with tiotropium for the treatment of COPD.

Perforomist Inhalation Solution is the first and only FDA-approved nebulized form of formoterol fumarate and is indicated for long-term, twice- daily maintenance treatment of bronchoconstriction for emphysema and chronic bronchitis, also known as Chronic Obstructive Pulmonary Disease (COPD). Nebulizers convert liquid medication into a mist that patients inhale through a mouthpiece or face mask.

For those attending CHEST, the three presentations are available as follows:

-- "Long-Term Safety of Nebulized Formoterol in COPD: An Open-Label Active-Control Extension Study" Poster # 239

-- "Cardiovascular Safety of Nebulized Formoterol in COPD Patients: A Double-Blind, Placebo-Controlled Study" Poster # 238

-- "Safety and Efficacy of Concomitant Treatment with Nebulized Formoterol and Tiotropium in COPD," Poster # 251

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.

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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.

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 are not 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. Because nebulization is an easy, effective, and thorough method of delivering medicine directly into the lungs, many COPD patients ask for it, 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 who are not adequately controlled with short-acting bronchodilators.

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