FDA approves Dey, L.P.'s NDA for chronic obstructive pulmonary disease inhalation solution

May 15 2007

Dey, L.P. has announced that the Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Perforomist (formoterol fumarate) Inhalation Solution for long-term, twice-daily maintenance treatment of bronchoconstriction for emphysema and chronic bronchitis, also known as Chronic Obstructive Pulmonary Disease (COPD).

Formoterol is a rapid and long-lasting beta2 agonist that has been previously approved in the U.S. as a dry powder formulation, and the molecule has twenty years of worldwide use. Perforomist Inhalation Solution is the first and only FDA-approved nebulized formoterol fumarate. Nebulizers convert liquid medication into a mist that patients inhale through a mouthpiece or face mask.

“The first nebulized formoterol fumarate, Perforomist Inhalation Solution offers a new treatment option to COPD patients,” said Nicholas J. Gross, MD, PhD, Principal Investigator of the Phase III pivotal clinical trial and an expert on lung diseases, particularly COPD. “By nebulizing with Perforomist Inhalation Solution twice a day – once in the morning and once in the evening – many COPD patients can achieve better control of their disease symptoms. The convenience of such simple dosing combined with a drug delivery option favored by many patients may provide improved symptom control and a better quality of life for the millions of Americans who live with COPD.”

Mel Engle, President and CEO at DEY, noted, “As the US leader in nebulized respiratory products, we are thrilled to bring Perforomist Inhalation Solution, a new patented treatment option for COPD patients, to the market. Nebulization is a time tested and reliable drug delivery option. DEY has a long history of developing and marketing innovative respiratory therapeutics. The approval of Perforomist Inhalation Solution fits perfectly with our overall strategy for respiratory medications.”

Gene L. Colice, MD, Department Director, Pulmonary, Critical Care and Respiratory Service, Washington Hospital Service, commented, “In my clinical experience, formoterol has been shown over many years to be an extremely effective clinical option for many COPD patients. It is a proven, well-understood compound whose fast onset of action combined with sustained symptomatic relief is highly stabilizing for many patients, offering them a safe and effective maintenance therapy. DEY's nebulized formoterol will be a valuable addition to the clinician's arsenal.”

FDA's approval of Perforomist Inhalation Solution is a significant milestone for the product as well as for DEY's continuing commitment to nebulized respiratory products and patients. The company expects to announce the commercial launch of Perforomist Inhalation Solution in the near future.

The clinical evaluations of Perforomist Inhalation Solution included two clinical trials involving a total of 1,045 patients. In the product's pivotal Phase III trial, 351 patients participated in a 12-week, multi-center, safety and efficacy COPD study. In the study, 123 COPD patients were treated with Perforomist Inhalation Solution 20 mcg/2 mL twice daily, 114 COPD patients were treated with the active comparator (Foradil®), and 114 COPD patients were treated with placebo. The study's results showed that Perforomist Inhalation Solution 20 mcg/2 mL taken twice daily was statistically superior to placebo for the primary endpoint, FEV1 AUC 0-12. The safety and efficacy of Perforomist Inhalation Solution observed in this study were comparable to those of Foradil®. Additionally, patients treated with Perforomist Inhalation Solution used less rescue albuterol during the trial compared to patients treated with placebo.