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Concomitant treatment with nebulized formoterol fumarate & tio-significant improvements -- COPD

Napa, CA, (May 20, 2008) A newly published study presents data demonstrating that patients with Chronic Obstructive Pulmonary Disease (COPD), including emphysema and chronic bronchitis, experienced markedly improved bronchodilation and symptom control when treated with a combination of nebulized formoterol fumarate inhalation solution (Perforomist Inhalation Solution) and tiotropium (TIO), compared to treatment with tiotropium alone. The two medications, when used adjunctively, were also well tolerated by patients over the course of the 6-week study.

Concomitant Treatment with Nebulized Formoterol and Tiotropium in Subjects with COPD: A Placebo-Controlled Trial, published in Respiratory Medicine, assesses the efficacy and safety of the concomitant treatment of Perforomist nebulized formoterol fumarate (a long-acting β-agonist [LABA]) and tiotropium (an anticholinergic) in 130 adults with moderate to severe COPD.

These data provide additional insight into the additive benefit of concomitant therapy with a LABA and a long-acting anticholinergic, said Dr. Donald Tashkin, MD, FACP, FCCP, Professor of Medicine, David Geffen School of Medicine at the University of California at Los Angeles, lead author and principal investigator of the study. When Perforomist Solutions rapid onset of action is combined with tiotropiums prolonged bronchodilation, the result appears to be a safe and effective treatment option for patients. This is great news for the millions of patients and their families -- who live with COPD, and who too often struggle with an insufficient number of robust treatment options.

About the Study

The study was a six-week, randomized, double-blind, placebo-controlled, parallel-group design study. COPD patients entered a 7-14 day run-in period during which subjects received once-daily treatment with tiotropium bromide inhalation powder (TIO; Spiriva, 18 g) administered with a HandiHaler. Following randomization, subjects entered a six-week treatment period to evaluate the safety and efficacy of formoterol fumarate inhalation solution (FFIS; Perforomist, 20 g/2mL) while maintaining once-daily treatment with TIO. The primary efficacy endpoint was standardized area under the curve for FEV1 over three hours (FEV1 AUC0-3) at the last visit (week 6).

The standardized absolute AUC0-3 for FEV1 following the first dose of study medication at Day 1 was statistically significantly improved in the Perforomist/TIO group compared with placebo/TIO group (PLA/TIO). FEV1 AUC0-3 remained significantly greater in the Perforomist/TIO group after six weeks without any decrease of effect or evidence of tolerance (p< 0.0001). Peak FEV1 levels were significantly higher in the Perforomist/TIO group compared with PLA/TIO (p< 0.0001). Symptoms, including shortness of breath, chest tightness, night-time awakenings, and the total respiratory symptom score, were all significantly improved in the Perforomist/TIO group compared with PLA/TIO. Use of albuterol rescue medication declined in the Perforomist/TIO group and remained low throughout the treatment, whereas albuterol use in the PLA/TIO group trended higher through the six weeks of treatment (p<0.0001), suggesting enhanced control of COPD symptoms.

Quality of life was assessed with St. Georges Respiratory Questionnaire (SGRQ), the results of which were similar at day 1 and did not change markedly over the six weeks of treatment. The only statistically significant and clinically relevant treatment difference observed with Perforomist/TIO compared with PLA/TIO was an improvement in symptom score (LS mean change of -5.8 units).

Other Recently Published Data

Results from the Phase III pivotal trial of Perforomist (formoterol fumarate) Inhalation Solution, the first and only FDA-approved nebulized formoterol fumarate, were also recently published. Perforomist Inhalation Solution is indicated for long-term, twice-daily maintenance treatment of COPD.

  • Efficacy and Safety of Formoterol Fumarate Delivered by Nebulization to COPD Patients, published in the February 2008 issue of Respiratory Medicine, detailed pivotal Phase III data that supported the NDA approval for Perforomist (formoterol fumarate) Inhalation Solution. The study demonstrated that Perforomist Inhalation Solution has a rapid onset of significant bronchodilation within five minutes of administration and is safe and effective. The study assessed the efficacy and safety of Perforomist Inhalation Solution in 351 adults with moderate-to-severe COPD. Nicholas J. Gross, MD, PhD, Hines VA Hospital, Stricht Loyola School of Medicine, was lead author and principal investigator of the study.

  • In October 2007, Clinical Therapeutics published cardiac safety results from the Phase III trial for Perforomist Inhalation Solution. In Cardiac Safety Profile of Nebulized Formoterol in Adults with COPD: A 12-Week, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Trial, the data showed that Perforomist Inhalation Solution was associated with rapid and sustained improvement in pulmonary function with no clinically significant cardiac effects, including QT prolongation, increased proarrhythmic events, or changes in serum potassium levels. Harold S. Nelson, MD, Professor of Medicine, National Jewish Medical and Research Center; was lead author of the article and principal investigator of the study. Patients with cardiac problems were excluded from the study. Perforomist should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrythmias, and hypertension.

Funding for these studies was provided by Dey, L.P., manufacturer and marketer of Perforomist (formoterol fumarate) Inhalation Solution. Perforomist Inhalation Solution is the first and only FDA-approved nebulized form of formoterol fumarate. Formoterol fumarate is a rapid and long-acting beta2-agonist (LABA) that has been previously available in the U.S. in a dry powder formulation with twenty years of worldwide experience. Nebulizers convert liquid medication into a mist that patients inhale through a mouthpiece or facemask.

Taken together, these studies expand our understanding of the clinical benefits of Perforomist Inhalation Solution for the treatment of COPD, said Carolyn Myers, Ph.D., President of Dey, L.P. Perforomist Inhalation Solution offers physicians a flexible, safe, and highly effective treatment option for COPD -- and many patients may benefit from this new addition to the treatment armamentarium.


Contact: Amy Techtmann
Feinstein Kean Healthcare

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